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# Synergy Bioscience

Scientific and Technical Services You Can Trust!

## Posts

- [The Importance of Endotoxin Testing and Choosing the Right Method for Your Needs](https://synergybioscience.com/the-importance-of-endotoxin-testing-and-choosing-the-right-method-for-your-needs/) - As a vital component of patient safety, endotoxin testing is essential for medical devices, injectables, and their raw materials. Endotoxins, small hydrophobic molecules found in the outer membrane of Gram-negative bacteria, can be released when bacteria die, triggering toxic reactions. Unfortunately, endotoxin testing is sometimes neglected, with many manufacturers relying heavily on sterility testing.
- [ISO 13485-2016 .. are you ready for the change?](https://synergybioscience.com/iso-13485-2016-are-you-ready-for-the-change/) - Is your risk management process ready for ISO 13485? Last year, the International Organization for Standardization (ISO) dramatically revamped its ISO 13485 standard, which sets rules for medical device makers to demonstrate quality control processes and make sure that devices sold to customers are safe and reliable. Certification ensures the ability to sell internationally; losing
- [Reporting cGMP changes to the FDA](https://synergybioscience.com/reporting-cgmp-changes-to-the-fda/) - Reporting changes in your manufacturing process to the FDA can be jarring, and sometimes disastrous. Having to do these reports is something best avoided. But I’m not suggesting anything illegal. Instead, I’ll present the (probably) ancient English phrase, “A stitch in time saves nine.” In other words, taking steps to make your pharmaceutical manufacturing process
- [Freeze Drying in Pharma | Lyophilization Guide for Drug Development](https://synergybioscience.com/freeze-drying-in-pharma/) - Freeze drying in pharma explained. Learn how lyophilization improves drug stability, shelf life, and product performance.
- [The Importance of Pharmaceutical Extractable/Leachable Testing and Synergy Bioscience’s Expertise](https://synergybioscience.com/the-importance-of-pharmaceutical-extractable-leachable-testing-and-synergy-biosciences-expertise/) - Partner with Synergy for expert extractable and leachable testing services to safeguard drug purity and packaging safety from development to launch.
- [Container Closure Integrity Testing – The Synergy Bioscience Advantage](https://synergybioscience.com/container-closure-integrity-testing-the-synergy-bioscience-advantage/) - Ensure sterility with Synergy’s advanced Container Closure Integrity Testing (CCIT) services—non-destructive, validated testing for secure pharmaceutical packaging compliance.
- [Characterization and Quantification using LC-MS/MS: The Synergy Bioscience Advantage in Protein Analysis](https://synergybioscience.com/characterization-quantification-lc-ms-ms/) - In today's fast-evolving pharmaceutical landscape, understanding complex biomolecules is paramount. The intricacies of protein structure and function can often be the linchpin determining the success of a new therapeutic or the precision of a diagnostic tool. This is where LC-MS/MS, or Liquid Chromatography-Tandem Mass Spectrometry, steps in as a revolutionary tool. For industry professionals well-acquainted
- [EXTRACTABLES AND LEACHABLES – A RISK-BASED APPROACH TO IDENTIFY AND QUANTIFY THE UNKNOWNS USING ORBITRAP LC-MS/MS, GC-MS, AND ICP-MS](https://synergybioscience.com/el/) - EXTRACTABLES AND LEACHABLES – A RISK-BASED APPROACH TO IDENTIFY AND QUANTIFY THE UNKNOWNS USING ORBITRAP LC-MS/MS, GC-MS, AND ICP-MS It is an undeniable fact that plastic has been woven into the fabric of modern pharmaceutical and biotech manufacturing processes, owing to its affordability, versatility, and functionality. Yet, these benefits are not without their drawbacks.
- [The Pivotal Role of Chemistry, Manufacturing, and Controls (CMC) in the Lifecycle of Pharmaceutical Drug Applications](https://synergybioscience.com/cmc/) - Pharmaceutical drug development and approval necessitate intricate and demanding procedures, which culminate in the presentation of a New Drug Application (NDA). A key component of this application is the Chemistry, Manufacturing, and Controls (CMC) section. The preparation and submission of this section, which has to adhere strictly to FDA regulatory requirements and the Common Technical
- [Comprehensive Pharmaceutical Formulation Development Services at Synergy Bioscience](https://synergybioscience.com/comprehensive-pharmaceutical-formulation-development-services-at-synergy-bioscience/) - At Synergy Bioscience, we understand that pharmaceutical and bio-pharmaceutical development is a complex process requiring expertise in various fields. Our comprehensive formulation development services cater to a wide range of molecules, including small chemical molecules and large protein molecules such as enzymes, monoclonal antibodies, growth factors, complex glycoproteins, and novel recombinant constructs. Whether you need
- [Dissolution Testing – A Vital Parameter in Evaluating Drug Product Quality](https://synergybioscience.com/dissolution-testing-a-vital-parameter-in-evaluating-drug-product-quality/) - Synergy Bioscience - Mastering Pharmaceutical Dissolution Testing Pharmaceutical dissolution testing stands as a cornerstone in evaluating drug product quality throughout the development and manufacturing stages. This pivotal test gauges the release of a drug's active substance within a controlled laboratory setting designed to emulate in-vivo conditions. It serves as an indispensable parameter for determining drug
- [EXTRACTABLE/LEACHABLE STUDIES: ENSURING QUALITY AND SAFETY IN THE PHARMACEUTICAL INDUSTRY WITH SYNERGY BIOSCIENCE](https://synergybioscience.com/extractable-leachable-studies-ensuring-quality-and-safety-in-the-pharmaceutical-industry-with-synergy-bioscience/) - Introduction The pharmaceutical industry is a highly regulated sector, with a primary focus on ensuring the safety, quality, and efficacy of medicinal products. One critical aspect of this process is the identification and quantification of extractables and leachables (E&L) in drug products and their packaging. These studies are essential for minimizing potential health
- [Unlocking the Power of Mass Spectrometry with Synergy Bioscience’s Advanced Solutions](https://synergybioscience.com/unlocking-the-power-of-mass-spectrometry-with-synergy-biosciences-advanced-solutions/) - Synergy Bioscience is at the forefront of harnessing the full potential of orbitrap mass spectrometry, providing cutting-edge solutions for a wide range of applications. This technology has become essential for the chemical characterization of pharmaceutical and biological products, accelerating development pipelines, and improving the quality and efficiency of life-changing therapeutics. In this blog post,
- [Stability Testing of Pharmaceuticals: Why is it important?](https://synergybioscience.com/stability-testing-of-pharmaceutical-products/) - Introduction Pharmaceutical stability studies are an essential component of drug development and regulatory approval. Stability testing allows you to understand how your product behaves under different conditions, such as temperature and humidity, and helps you to determine its shelf life and storage conditions. At Synergy Bioscience, we offer pharmaceutical stability program development and testing
- [When FDA recommends a consultant](https://synergybioscience.com/when-fda-recommends-a-consultant/) - As a regulatory agency, the FDA expects that organizations that they audit will take appropriate measures to ensure that they remain in compliance with the regulations. In the event that the FDA determines that a particular organization consistently gets reprimanded for non-compliance, they will likely look into the Quality System of the organization to make
- [EU IVDR – Understanding The key changes and Their impact](https://synergybioscience.com/eu-ivdr-understanding-the-key-changes-and-their-impact/) - How the new EU IVDR regulations came to existence? What impact these changes in regulations will have on your business? In May 2017, the EU published the in vitro diagnostic medical devices regulation (IVDR), in response to several scandals of harmful medical devices such as the substandard French-made breast implant. Together with the accompanying Medical
- [Drug product recalls - why they happen](https://synergybioscience.com/drug-product-recalls-why-they-happen/) - Recently, Claris Lifescience Ltd., a maker of injectable pharmaceuticals in India, received a warning letter from the FDA that no firm wants to see: “…Your firm received a complaint from a U.S. distributor (Sagent Pharmaceuticals) informing you that Metronidazole Injection USP IV bags (lot A090744) were contaminated with a swirling mass, which the complainant identified
- [A Wake-Up Call for Generics-Makers: FDA Accepting Only Electronic Submission in 2017](https://synergybioscience.com/a-wake-up-call-for-generics-makers-fda-accepting-only-electronic-submission-in-2017/) - Generic drugs have saved billions of dollars for health care consumers, providers and payers. And the market shows no signs of slowing down. According to the US Food and Drug Administration (FDA), nearly 8 in 10 prescriptions filled in the United States are for generic drugs, totaling more than $70 billion in 2014.This demand has
- [Your Change Management Process … What Went Wrong?](https://synergybioscience.com/your-change-management-process-what-went-wrong/) - A long-time client of ours called us recently, asking for help. The client found itself under a consent decree by the FDA. It turned out that the decree was issued mainly because of repetitive problems with their CAPA investigations. When we visited the client, we ended up rewriting their CAPA process. However, implementing the new
- [Consent decrees is not a death sentence](https://synergybioscience.com/consent-decrees-is-not-a-death-sentence/) - The article in the Dallas Morning News was something no pharmaceutical manufacturer wants to see. The headline, “Farmers Branch pharmacies highlight lack of government oversight of custom-made drugs,” may at first appear to attack government regulations, but the article instead claimed that the managers of what is now Downing Labs refused to allow FDA inspectors
- [Of Mad Cows and Superior Supplier Quality Audits](https://synergybioscience.com/of-mad-cows-and-superior-supplier-quality-audits/) - In the 1980s, British health and agricultural officials started receiving reports of cows with symptoms of neurological disease. This disease erupted into an epidemic (in Britain) of bovine spongiform encephalitis (BSE), and the scourge of “Mad Cow Disease” was born. The disease, caused by a prion, crossed over to humans to become new variant Creutzfeld
- [Sailing through clinical trial audits](https://synergybioscience.com/sailing-through-clinical-trial-audits/) - The arrival of FDA inspectors to evaluate your clinical trial program (or your CRO’s program) doesn’t have to be a jarring experience. But too often, it is. FDA clinical investigators most often find discrepancies such as: • Not following the investigational plan. • Deviating from the established and approved protocol. • Inadequate record keeping. •
- [Toward a brave new world of GMP consistency](https://synergybioscience.com/toward-a-brave-new-world-of-gmp-consistency/) - The New York Attorney General’s sweeping investigation of nutritional supplement manufacturing practices last year sent waves through the supplement and drug manufacturing industries. One solid defense these industries could agree on was ensuring that drug- and supplement-makers fully understood GMP (good manufacturing practices). But understanding GMP and implementing it are two different stages of key
- [Consent Decree - why it is so serious?](https://synergybioscience.com/consent-decree-why-it-is-so-serious/) - A Consent Decree takes a tremendous toll on an organization, with a typical decree lasting between 5 to 7 years, and aggregated costs amounting to more than $500 million in fines, penalties, remediation expenses and lost sales. In addition to its major economic impact, consent decrees can severely damage a company’s reputation with both its
- [Good planning can save time](https://synergybioscience.com/good-planning-can-save-time/) - One of my biotechnology clients hired me to conduct a quality system gap assessment. During my first day of work, I participated in a conference call with the top management of the company. The conference call allowed the top management to identify for me which departments were the sources of their business issues, and where
- [The Most Important Details of a Corrective Action Plan - (CAPA)](https://synergybioscience.com/the-most-important-details-of-a-corrective-action-plan-capa/) - Imagine the sheer volume of warning letters the FDA sends out to companies who are not meeting FDA regulations. The companies will no doubt reply back with a presentation to resolve the FDA compliance issues right? With the sheer volume of work involved would the FDA show any remorse for these companies? Generally the answer
- [Top Ten FDA Warning Letter Observations](https://synergybioscience.com/top-ten-fda-warning-letter-observations/) - An anecdotal review of recent FDA warning letters provides key insights to pharmaceutical companies about how they can improve their quality systems, their manufacturing processes and most importantly, manage future FDA inspections. Some surprising information culled from the GMP warning letters issued recently include the following:• Approximately 80 percent of the the FDA-issued GMP warning
- [A case study in CAPA remediation](https://synergybioscience.com/a-case-study-in-capa-remediation/) - I was asked by one of my clients to optimize their CAPA process, in preparation for the next FDA inspection occurring at one of their manufacturing sites. The following tasks for this project were required to be completed within a 5- month time frame:a. Review 120 CAPA records,b. Document my review on a remediation form,c.
- [FDA Inspections](https://synergybioscience.com/fda-inspections/) - I am often asked how best to prepare for an FDA inspection when you know that you have problems. My first response is that they have already taken the first step: acknowledging that there are problems. Believe me. That is a huge first step. Just like AA’s 12 step program, it’s not until you are
- [FDA Enforcement Inflation: What's Next?](https://synergybioscience.com/fda-enforcement-inflation-whats-next/) - I grew up in a home where just a cast of my mother's glance was enough to cause me to stop dead in my tracks. I knew "the look" quite well. There were no raised voices. When a parent doesn't follow through on the gentlest of correction, then the parent is communicating that an appropriate
- [Data Talk - Opinions Walk: Justification vs. Rationalization](https://synergybioscience.com/data-talk-opinions-walk-justification-vs-rationalization/) - I was a judge for a junior high school science fair where young minds applied the scientific method to everything from bean sprouts to producing amino acids from primordial ooze. It was great to see creative minds at work as each explained their hypothesis, methods of observation, data collection and conclusions. Of course, I took
- [Company Culture and CGMP Compliance](https://synergybioscience.com/company-culture-and-cgmp-compliance/) - I’ve come to the conclusion that compliance with the FDA Current Good Manufacturing Practices (CGMP) is just as much about company culture as it is about anything else. A corollary to this is that resolution of regulatory compliance problems is just as much about organization transformation as anything else. I have divided companies with significant
- [Current Pharmaceutical Industry CGMP Compliance Trends](https://synergybioscience.com/current-pharmaceutical-industry-cgmp-compliance-trends/) - It must be that time of year again when conference planners rack their brains on how to bolster dwindling attendance, because several have contacted me through this blog to ask my opinion on major trends in the pharmaceutical industry. So with this edition I offer my opinion not only to those conference planners, but also
- [Two different organization cultures](https://synergybioscience.com/two-different-organization-cultures/) - The essence of a society is found within its culture. This culture is deeply engrained within each individual, and cannot be changed by merely manipulating superficial policies & procedures. When change is needed, it is the leaders of a society who must pioneer changes. Leaders will determine the morale of their people, and it is
- [A Tale of Two Deviations](https://synergybioscience.com/a-tale-of-two-deviations/) - It stands to reason that pharmaceutical companies in compliance trouble also have problems with their Deviation Management and Corrective and Preventive Action (CAPA) System(s). After all, to maintain a good compliance profile, as well as an efficient operation, requires the ability to detect problems, determine the root cause and permanently eliminate the problems.Good companies are
- [Are Commitments Made to FDA to be Taken Seriously?](https://synergybioscience.com/are-commitments-made-to-fda-to-be-taken-seriously/) - Responses to FD483’s and Warning Letters are usually fully of commitments. They involve “what” will be done to correct compliance problems, and “when” it will be done. FDA has even started to ask “how” they will be done, meaning—Do you have the resources to do the work? If these questions are not fully addressed in
- [FDA Audits .. Are You Ready?](https://synergybioscience.com/fda-audits-are-you-ready/) - As we all know, FDA audit observations and warning letters can be costly to the existence of a company, and it is in the best interest of a company to comply and correct any discrepancies in a timely manner. The best way for a company to deal with any observations or warnings is to correct
- [Warning Letters and your commitment to the FDA](https://synergybioscience.com/warning-letters-and-your-commitment-to-the-fda/) - According to the Federal Food, Drug, and Cosmetic Act, SEC. 704 (21 USC §374), the FDA is authorized to perform inspections on a regulated premises. Any compliance concerns or discrepancies are addressed by the FDA inspectors via form FD-483 or Warning Letter. It is in the best interest of the organization to respond to observations
- [Challenges in Developing Biopharmaceutical Drugs](https://synergybioscience.com/challenges-in-developing-biopharmaceutical-drugs/) - Right now, the process of biologics development and manufacturing is an ever-evolving area. Many new products, largely produced by recombinant DNA, are introducing new treatments for previously untreated diseases, or more targeted, effective treatments for today’s health challenges. On the surface, these products seem wildly diverse: monoclonal antibodies, vaccines, hormones, interferons, interleukins, thrombolytic factors. But
- [Developing and validating analytical methods - what’s your objective?](https://synergybioscience.com/developing-and-validating-analytical-methods-whats-your-objective/) - Recently, the US Food and Drug Administration (FDA) cited a pharmaceutical manufacturer for not validating an analytical method. The drug maker’s answer was that the sample matrix was too complex for the method to be fully validated. As you would guess, this answer did not amuse the agency. As we all know, analytical methods play

## Pages

- [Home](https://synergybioscience.com/) - Synergy Bioscience provides pharmaceutical development, microbiology testing, analytical chemistry, bioanalytical services, regulatory support, and laboratory testing solutions for biotech, pharmaceutical, and medical device industries.
- [Case Studies](https://synergybioscience.com/case-studies/) - Explore Synergy Bioscience case studies showing successful pharmaceutical and biotech projects, innovative research solutions, and proven scientific expertise.
- [Organic Synthesis](https://synergybioscience.com/pharmaceutical-development-services/organic-synthesis-services/) - Accelerating Drug Development Through Expert Organic Synthesis Synergy Bioscience offers world-class organic synthesis services, leveraging the expertise of our highly skilled scientists and advanced laboratory infrastructure to accelerate your drug development journey. As a fully integrated Contract Research Organization (CRO), we provide the specialized technical mastery required to synthesize complex organic molecules, including the challenging
- [Pharmaceutical Development](https://synergybioscience.com/pharmaceutical-development-services/) - We provide pharmaceutical development services including formulation, CMC, and analytical support. Fast, reliable results.
- [Biologics Development](https://synergybioscience.com/pharmaceutical-development-services/biopharma-development-services/) - Biopharma development services covering drug discovery, protein production, cell-based assays, and preclinical screening. Reliable CRO support.
- [Computer System Validation](https://synergybioscience.com/quality-compliance-consulting/validation-studies/computer-system-validation/) - The process of ensuring compliance with 21 CFR Part 11 has always been a challenge for life science companies, as it requires unquestionable evidence that the organization is following the FDA regulations in this regard. Even with the use of a Quality Management System (QMS) software, compliance for digital signatures and documentation for FDA 21
- [Cleanroom & Water System Validations](https://synergybioscience.com/quality-compliance-consulting/validation-studies/cleanroom-water-system-validations/) - CLEANROOM VALIDATION A cleanroom is a controlled environment where the concentration and size of airborne particles per cubic meter (or per cubic foot) are tightly regulated. Cleanrooms are indispensable in pharmaceutical and medical device research and manufacturing for the control of particle contamination and other critical environmental factors, including temperature, humidity, and pressure. Cleanrooms are
- [Sterilization process validation](https://synergybioscience.com/quality-compliance-consulting/validation-studies/sterilization-process-validation/) - The objective of the sterilization process validation is to determine that the manufacturer’s current sterilization process can consistently achieve sterility and does not cause any undesirable effect on the product or its packaging. Elements of the validation process There are some common elements in any sterilization process validation which should be adequately addressed, these include:
- [Process Validation](https://synergybioscience.com/quality-compliance-consulting/validation-studies/process-validation/) - Process validation has been a major focus of the FDA in recent years. Our team has extensive experience in both setting up and monitoring process validation programs. This is an area where having the latest information makes all the difference. It is critical to begin thinking about process validation during the early stages of product
- [Cleaning Validation](https://synergybioscience.com/quality-compliance-consulting/validation-studies/cleaning-validation/) - Do you know what are the various elements of a cleaning validation program? How do you know if these elements have been established and implemented in a way that will pass the scrutiny of regulatory audits? Do you know how many FDA Warning Letters / Form 483 have been issues because of cleaning validations in
- [Validation Studies](https://synergybioscience.com/quality-compliance-consulting/validation-studies/) - When it comes to validation, it is always true that the whole is greater than the sum of the parts. When the proper relationships between validation and the other firm’s activities are established, there is a synergic effect of greater compliance and some tangible operating benefits. In other words, validation is not a standalone activity;
- [CAPA Investigations](https://synergybioscience.com/quality-compliance-consulting/capa-investigations/) - A CAPA system is not only a regulatory requirement; it makes good-business sense to pharmaceutical and other life science companies. An effective CAPA process is capable of feeding the other processes of your Quality System to improve its processes, procedures, organization, and the overall business in a structured, well-documented and actionable manner. There is a
- [Equipment Qualification (IQ/OQ/PQ)](https://synergybioscience.com/quality-compliance-consulting/equipment-qualification-iq-oq-pq/) - EQUIPMENT AND FACILITY QUALIFICATION Many companies assume that since process validation does not have to be completed until your product nears market production, the same is true for equipment qualification. However, the FDA and other regulators expect critical equipment qualification and sterilization validation to be completed before beginning the manufacture of any drug intended for
- [Quality System Development](https://synergybioscience.com/quality-compliance-consulting/quality-system-development/) - Understanding the needs, requirements, and how to implement a quality system can be a daunting task. Organizations waste a great deal of time and money in trying to understand what they need to do and how to do it. This time and money can be better spent in improving the business and providing products or
- [cGMP Auditing & Training](https://synergybioscience.com/quality-compliance-consulting/cgmp-auditing-training/) - Synergy provides cost-effective training programs and materials for regulatory compliance. We develop and produce customized, competency-based training courses, designed to help organizations improve employee competence and skills. Our expert trainers are experienced hands-on practitioners in their field, taking training beyond theory, providing your employees valuable real-world insight. Throughout our course curriculum, we provide high-quality consistent
- [Quality system gap assessment](https://synergybioscience.com/quality-compliance-consulting/quality-system-gap-assessment/) - The QMS Gap Assessment is critical to ensure product development and manufacturing meets the regulatory requirements as a condition for a successful commercialization. A gap analysis attempts to identify whether the company has adequate processes, personnel, documentation and system in place to undertake a clinical trial that fulfils regulatory requirements for product marketing authorization. In
- [Post market surveillance & MDR](https://synergybioscience.com/quality-compliance-consulting/post-market-surveillance-mdr/) - POST-MARKET SURVEILLANCE AND MEDICAL DEVICE REPORTING Post-market surveillance (PMS) programs are indispensable in a medical device development plan. It is a regulatory requirement for many countries such as the United States and European Union. Under PMS, a medical device manufacturer has the obligation to continuously monitor the use of their products after it is approved
- [Supplier Audits](https://synergybioscience.com/quality-compliance-consulting/supplier-audits/) - Why Synergy Bioscience for GXP Audit Solutions? If your current program for audits consist of employees tied to your organization, your audit has already failed
- [Regulatory Filing Services](https://synergybioscience.com/quality-compliance-consulting/regulatory-filing-services/) - The contents of a regulatory submission convey the first impression the FDA will have of your product and the quality and professionalism of your organization. It has been proven consistently that the success of a new product application is dependent on the effectiveness of the organization’s submission team and the working relationship developed between this
- [FDA Pre-Approval Readiness](https://synergybioscience.com/quality-compliance-consulting/fda-pre-approval-readiness/) - After many years of hard work, and coordination between different departments and outsourcing activities, you submitted your application to the FDA for approval. How you can ensure a positive outcome to the FDA pre-approval visit? There are many factors you need to ensure that they are in place to get the positive outcome of this
- [FDA Audit Remediation](https://synergybioscience.com/quality-compliance-consulting/fda-inspection-remediation/) - Transform Your Quality Compliance with Synergy Bioscience In the highly regulated world of medical devices, a single FDA audit revealing noncompliance can have catastrophic consequences. One large medical devices company learned this the hard way. After receiving a Form 483 for significant noncompliance issues, they failed to take decisive action due to inadequate resources or
- [Freeze Dry / Lyophilization](https://synergybioscience.com/pharmaceutical-development-services/lyophilization-services/) - Lyophilization services for pharmaceuticals including freeze drying, cycle development, and process optimization. Reliable CRO support for stable drug products.
- [Antibody Oligonucleotide Conjugates](https://synergybioscience.com/pharmaceutical-development-services/antibody-oligonucleotide-conjugate-development/) - Antibody oligonucleotide conjugate development services including bioconjugation, linker design, and oligonucleotide delivery. Scalable AOC CRO support.
- [Antibody Drug Conjugates](https://synergybioscience.com/pharmaceutical-development-services/antibody-drug-conjugate-development/) - Antibody drug conjugate development services including bioconjugation, linker-payload design, and analytical support. Reliable CRO for targeted therapeutics.
- [Microbiology Testing](https://synergybioscience.com/analytical-testing-services/microbiology-testing-services/) - Microbiology testing services for pharmaceutical products, ensuring USP compliance, product safety, and accurate microbial analysis.
- [Dissolution Testing](https://synergybioscience.com/analytical-testing-services/dissolution-testing/) - Synergy’s dissolution testing ensures precise drug release profiling, supporting bioavailability, formulation optimization, and regulatory success.
- [Biocompatibility Testing](https://synergybioscience.com/analytical-testing-services/biocompatibility-testing/) - Biocompatibility evaluation of a medical devices include chemical toxicity, unacceptable biological response to the medical device or changes in the device’s physicochemical characteristics due to any aspects of the manufacturing process. In addition to the International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”,
- [Drug Metabolism](https://synergybioscience.com/clinical-research/drug-metabolism/) - At Synergy Bioscience, we are dedicated to advancing the field of drug development with our broad suite of Drug Metabolism and Pharmacokinetics (DMPK) services.
- [Pharmacokinetics](https://synergybioscience.com/clinical-research/pharmacokinetics/) - At Synergy Bioscience, our pharmacokinetics services are the core of the drug development plan, providing insights into the safety and efficacy of therapeutics.
- [Pharmacodynamics](https://synergybioscience.com/clinical-research/pharmacodynamics/) - Synergy Bioscience is at the forefront of pharmacodynamics (PD) studies, playing a pivotal role in the early stages of drug development.
- [Biomarkers](https://synergybioscience.com/clinical-research/biomarkers/) - Synergy Bioscience offers an extensive array of biomarker analysis services for large molecules, small molecules, and Advanced Therapy Medicinal Products.
- [Immunogenicity](https://synergybioscience.com/clinical-research/immunogenicity/) - Immunogenicity presents a complex challenge in drug development, with potential consequences ranging from negligible to life-threatening.
- [CMC Bioanalytical](https://synergybioscience.com/clinical-research/cmc-bioanalytical/) - Our commitment to individualized CMC bioanalytical strategies is the cornerstone of our operations, catering to the unique demands of every therapeutic program.
- [Success Stories](https://synergybioscience.com/success-story/) - In Pursuit of Excellence: Recent Extractable/Leachable Study Reaffirms Our Commitment to Pharmaceutical Safety Synergy Bioscience, a Contract Research Organization specializing in product development, analytical chemistry, microbiology testing, and quality system compliance consulting services, recently completed an important project that highlights our core expertise. We designed and executed an Extractables and Leachables (E&L) Study for medical-grade
- [Clinical Research](https://synergybioscience.com/clinical-research/) - Our clinical research includes: Drug metabolism studies, Pharmacokinetics, Pharmacodynamics, Immunogenicity studies, Biomarker and CMC Bioanalytical studies
- [Stem Cell Research](https://synergybioscience.com/pharmaceutical-development-services/stem-cell-research-services/) - Stem cell research services for cell therapy development, including sourcing, characterization, and cGMP processing. Trusted CRO for biotech and pharma.
- [Cannabinoids Testing](https://synergybioscience.com/analytical-testing-services/cannabinoid-testing/) - Synergy Bioscience provides accurate cannabinoid testing services using HPLC, LC-MS/MS, ICP-MS/MS, and GC-MS technologies for product safety and compliance.
- [Laboratory Testing](https://synergybioscience.com/analytical-testing-services/) - Laboratory testing services for pharmaceuticals and biologics. Method development, validation, and regulatory-compliant testing by Synergy Bioscience.
- [Residual Solvents Testing](https://synergybioscience.com/analytical-testing-services/residual-solvents-testing/) - Synergy offers precise residual solvents testing to meet ICH Q3C standards and support safe, compliant pharmaceutical product development.
- [Product Stability Testing](https://synergybioscience.com/analytical-testing-services/stability-testing-lab/) - Our Stability Testing lab delivers reliable shelf-life data through real-time and accelerated studies, supporting global regulatory submissions.
- [Container Closure Integrity Testing](https://synergybioscience.com/analytical-testing-services/container-closure-integrity-testing/) - Container closure integrity testing (CCI) to detect leaks, ensure sterility, and protect pharmaceutical product quality and safety.
- [Structural Chemistry](https://synergybioscience.com/analytical-testing-services/structural-chemistry-services/) - Structural chemistry services for molecular profiling, structure elucidation, and impurity analysis supporting pharmaceutical development.
- [Elemental Impurities](https://synergybioscience.com/analytical-testing-services/elemental-impurities-testing/) - Elemental impurities testing services for pharmaceuticals using ICP-MS and ICP-OES. Ensure ICH Q3D compliance, safety, and accurate trace metal analysis.
- [Extractables and Leachables](https://synergybioscience.com/analytical-testing-services/extractables-and-leachables-testing/) - Extractables and leachables testing for pharmaceutical products to detect contaminants, ensure safety, and support regulatory compliance.
- [Analytical Chemistry](https://synergybioscience.com/analytical-testing-services/analytical-chemistry-services/) - Analytical chemistry services for pharmaceuticals and biologics. Method development, validation, and advanced testing solutions by Synergy Bioscience.
- [Formulation Studies](https://synergybioscience.com/pharmaceutical-development-services/pharmaceutical-formulation-development-services/) - Formulation development services including preformulation stability studies lyophilization and drug product testing Reliable CRO support for pharma and biotech.
- [Careers](https://synergybioscience.com/careers/) - The true measure of excellence at Synergy Bioscience is found neither in the advanced equipment we utilize nor the facilities we house. Instead, it resides in our unparalleled capability and our commitment to getting things done right the first time. Our success is rooted in a workplace culture that rejects the middle ground and demands
- [QA / RA Consulting](https://synergybioscience.com/quality-compliance-consulting/) - Why Trust Synergy Bioscience with Your Quality System Compliance? Our experienced teams complete projects on time and within budget while providing continuous on-site and remote support. We handle all regulatory submissions (NDAs, ANDAs, BLAs, PMAs, 510(k)) on your behalf and guarantee our commitment until you secure approval. We deliver customized GMP quality management systems that
- [Accreditation](https://synergybioscience.com/accreditation/) - We recognize that timely delivery and competitive pricing are crucial to the success of your project. ​However, we never compromise on quality to meet these goals. ​Instead, we’ve built a robust quality system that ensures full regulatory compliance while maintaining operational efficiency. Our accreditations, certifications, and licenses demonstrate our dedication to meeting the highest industry
- [Partner With Us](https://synergybioscience.com/partner-with-us/) - Accelerate Product Success with Synergy Bioscience: Expert Development, Testing & Compliance Synergy Bioscience is not just another CRO. We combine years of expertise and deep understanding in the life science sector, helping your organization benefit from our advanced capabilities. Our commitment to quality, speed, and a very competitive cost is what sets us apart. Our
- [Contact Us](https://synergybioscience.com/contact-us/)
- [For Investors](https://synergybioscience.com/for-investors/) - Join Synergy Bioscience in Pioneering the Future of The Life Science IndustriesOur expertise as a Contract Research Organization (CRO) and consultancy drives the life science industries forward, making us a beacon for efficient, swift, and transformative solutions. The secret to our success? Quality, speed, and cost-efficient solutions. As a company focused on R&D, analytical chemistry,
- [About Us](https://synergybioscience.com/about/) - A Word from The Founder … Our tale begins in the vibrant mid-eighties, where my career in pharmaceutical development and validation took flight. It was during this prolific period that I was privileged to contribute to the birth and commercialization of five significant drug products. This era bestowed upon me a wealth of knowledge about
- [Vaccine Development](https://synergybioscience.com/vaccine-development/) - A vaccine is a biological mix that makes the body more resistant to diseases. Vaccine production is getting better, with cutting-edge technologies that can deal with both new and old strains of viruses. We have scientists who are experts in drug delivery and synthesis, and they use the latest artificial intelligence (AI) technologies to speed
- [mRNA Vaccine](https://synergybioscience.com/mrna-vaccine/) - Scientists had to make a vaccine quickly because SARS-CoV-2 was spreading like a virus. The use of mRNA to make a vaccine and its success have brought mRNA technology to the forefront. mRNA is the future of vaccines, and its technology is the key to preventing and treating a wide range of cancers, metabolic diseases,
- [Biologics downstream process validation](https://synergybioscience.com/quality-compliance-consulting/validation-studies/biologics-downstream-process-validation/) - When it comes to biologics downstream, we all know that the product characteistics relies heavily on the process. Simply put; the product is the process. So, effective biologic or biopharmaceutical downstream process validation contributes significantly to assuring product quality. Biologic downstream processing (DSP) refers to the recovery and purification of a drug substance from natural
- [Injectables Process Validation](https://synergybioscience.com/quality-compliance-consulting/validation-studies/injectables-process-validation/) - Identifying and establishing the relationship between the injectable product critical quality attributes and the manufacturing critical processing parameters are keys to completing a successful injectable process validation. The final version of the U.S. FDA guidance on process validation emphasizes the evaluation of data which establishes scientific evidence throughout the process life cycle. The three-stage life
- [Bio Process Validation](https://synergybioscience.com/quality-compliance-consulting/validation-studies/bio-process-validation/) - Synergy Bioscience has a lot of experience in designing GMP facilities so they will be easy to keep clean, have logical product and personnel flow, and pass regulatory scrutiny. Synergy Bioscience can support you by Reviewing your current design plans Helping you figure out a scientifically based remodel Helping you investigate problem areas Informing you
- [Medical Devices Quality System](https://synergybioscience.com/quality-compliance-consulting/medical-devices-quality-system/) - Synergy Bioscience is a leader in the medical device consulting industry, focused on delivering strategic regulatory planning and support, FDA and international regulatory submissions, and unmatched quality assurance and compliance services to address FDA QSR and ISO 13485. We understand that Quality Systems and practices are paramount in Medical Device Development. That’s why all the
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- [Join Our Webinar](https://synergybioscience.com/webinar/) - Please join our WebinarSummary Please Join Us on August 10, 2026 Check out live demos of Synergy Biosciences pharmaceuticals built by our community. See how we can help resolve your unique business problems. Error: Contact form not found. To learn more on how Synergy Bioscience can support your organization, please contact us

## Event

- [Native Tree Planting Contest](https://synergybioscience.com/event/native-tree-planting-contest/) - Mauris id enim id purus ornare tincidunt. Aenean vel consequat risus. Proin viverra nisi at nisl imperdiet auctor. Donec ornare, est sed tincidunt placerat, sem mi suscipit mi, at varius enim sem at sem. Fusce tempus ex nibh, eget vulputate ligula ornare eget. Nunc facilisis erat at ligula blandit tempor. Mauris iaculis magna ipsum, sit
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## Testimonials

- [Doug Ramsey](https://synergybioscience.com/testimonial/doug-ramsey/) - Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque penatibus et magnis dis parturient montes. Nascetur ridiculus mus, donec quam felis, ultricies nec, pellentesque eu, pretium sem.
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## Team Member

- [Richard David](https://synergybioscience.com/team/richard-david/) - There are many variations of passages of Lorem Ipsum available, but the majority have suffered alteration. If you are going to use a passage of Lorem Ipsum, you need to be sure there isn’t anything embarrassing hidden in the middle of text. All the Lorem Ipsum generators on the Internet tend to repeat predefined chunks
- [Elina Bell](https://synergybioscience.com/team/elina-bell/) - There are many variations of passages of Lorem Ipsum available, but the majority have suffered alteration. If you are going to use a passage of Lorem Ipsum, you need to be sure there isn’t anything embarrassing hidden in the middle of text. All the Lorem Ipsum generators on the Internet tend to repeat predefined chunks
- [Gloria Mann](https://synergybioscience.com/team/gloria-mann/) - There are many variations of passages of Lorem Ipsum available, but the majority have suffered alteration. If you are going to use a passage of Lorem Ipsum, you need to be sure there isn’t anything embarrassing hidden in the middle of text. All the Lorem Ipsum generators on the Internet tend to repeat predefined chunks
- [Jorge Canaveral](https://synergybioscience.com/team/jorge-canaveral/) - There are many variations of passages of Lorem Ipsum available, but the majority have suffered alteration. If you are going to use a passage of Lorem Ipsum, you need to be sure there isn’t anything embarrassing hidden in the middle of text. All the Lorem Ipsum generators on the Internet tend to repeat predefined chunks
- [Mark Donald](https://synergybioscience.com/team/mark-donald/) - There are many variations of passages of Lorem Ipsum available, but the majority have suffered alteration. If you are going to use a passage of Lorem Ipsum, you need to be sure there isn’t anything embarrassing hidden in the middle of text. All the Lorem Ipsum generators on the Internet tend to repeat predefined chunks

## Categories

- [Knowledge Center](https://synergybioscience.com/category/knowledge-center/) - Welcome to Synergy Bioscience’s Knowledge Center, your go-to resource for understanding our services and exploring real-world case studies. Deepen your insights into the transformative power of bioscience through our articles and detailed analyses.