Synergy Bioscience provides laboratory testing services with a strong focus on analytical chemistry, microbiology, and regulatory compliance.
We deliver reliable and timely testing solutions to support pharmaceutical and biologic development. Our capabilities include method development, validation, and compendial testing in accordance with USP/NF, EP, BP, JP, ACS, AOAC, ISO/IEC 17025, and ISO 10993 standards. We also support raw materials, in-process analysis, and finished product release testing.
Our team specializes in a wide range of drug products, substances, and dosage forms, including tablets, capsules, semi-solids, parenteral, sterile, transdermal, and inhalation products. Since 2016, we have built a strong reputation for quality, accuracy, and turnaround time.
Our laboratory testing services are designed to support pharmaceutical development from early research through regulatory submission.
Analytical Chemistry
At Synergy, our mission is to provide you with the analytical solutions you need to achieve your drug development goals quickly and easily. We have the expertise in developing analytical methods for a wide range of drug products, including chemical molecules and therapeutic protein molecules.
Structural Chemistry
Synergy has the expertise that goes beyond chemical characterizations to include a deep understanding of all facets of drug development that can impact the successful development and launch of a product. This includes experience analyzing different routes of administration, meeting regulatory requirements, solving packaging issues, and identifying potential problems in manufacturing. With in-depth academic history, diverse industry experience, and influential industry involvement, Synergy’s structural chemists are unsurpassed.
Microbiology Testing
Choose Synergy Bioscience for your microbiology testing needs. We deliver a suite of tests that comply with all the USP General Chapters, ensuring the highest standards of microbiological testing for both sterile and non-sterile products. We uphold the highest industry standards while providing effective, efficient, and compliant testing services for your products.
Container Closure Integrity Testing
We perform container closure integrity testing (CCIT) that supports sterility, stability, and long-term product quality. Our laboratory team utilizes advanced techniques, including vacuum decay, headspace gas analysis, laser-based headspace analysis, microbial challenge, high-voltage leak detection, dye ingress, pressure decay, mass spectrometry, and microscopy. These methods detect leaks, breaches, and micro-defects that can compromise product safety or lead to recalls.
Extractables and Leachables
Monomers and polymer additives such as antioxidants, plasticizers, stabilizers, dyes, metal catalysts, and other harmful chemicals may potentially migrate into the product under storage conditions. Synergy Bioscience provides a complete service for testing extractables in container materials and leachables in final products. These tests are conducted in cGMP-compliant laboratories using technologies that detect ultra-trace levels.
Elemental Impurities
With decades of experience in both chemical analysis and regulatory issues, we provide industry-leading, highly accurate element-specific protocols, advanced analytical method development, and validation in accordance with USP 232, 233, and ICH Q3D guidelines for testing elemental impurities in drug products, down to the necessary trace level limits of detection.
Product Stability Testing
Synergy Bioscience has the technical expertise to develop and implement a custom-designed and compliant Stability program for your drug product, ensuring a smooth approval of your drug product application. We will write the Stability protocol, define the required samples, develop and validate the required analytical methods, verify that the stability chambers are properly calibrated and ready for the storage of your samples, monitor the storage conditions, review and evaluate the analytical results, compile the data, and write the Stability Report for your filing.
Dissolution Testing
Dissolution testing is crucial in drug development and manufacturing, as it provides the only standardized approach to generate data that can predict bioavailability, establish the stability of the dosage form, and indicate any changes in manufacturing processes. To accurately simulate in vivo conditions in a dissolution test, the selection of test apparatus and method parameters, such as the composition of the medium, pH levels, and sample collection frequency, must be adapted to the dosage form and the specific objectives of the test. Partnering with Synergy Bioscience assures precise, dependable, and timely dissolution testing outcomes.
Residual Solvents Testing
The U.S. Pharmacopeia defines daily exposure limits for solvents used in manufacturing and classifies them into three classes: Class 1 (should never be used), Class 2 (use only under strict cGMP controls due to hazards), and Class 3 (no known human health hazard at typical pharmaceutical levels). Monitoring residual solvent levels identifies contaminated raw materials and products. Synergy Bioscience uses gas chromatography (FID/TCD), headspace analysis, and mass spectrometry to detect common solvents and trace chemical residues throughout the manufacturing process.
Phytochemical Analysis
Synergy Bioscience provides precision analytical testing for industrial hemp and complex botanical extracts. As a DEA-licensed facility and ISO-certified laboratory, we offer the high-caliber oversight required for global regulatory compliance. Our state-of-the-art instrumentation delivers accurate quantification of potency profiles and purity standards, ensuring your agricultural products meet the most rigorous safety requirements. We provide reliable, world-class data validation for licensed businesses seeking to verify product integrity and maintain legal market access.
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.
Clinical Research
At Synergy Bioscience, we’re at the forefront of clinical research, offering an integrated suite of services that encompass drug metabolism studies, pharmacokinetics, pharmacodynamics, immunogenicity studies, biomarker studies, and CMC bioanalytical studies.
Drug Metabolism
At Synergy Bioscience, we are dedicated to advancing the field of drug development with our comprehensive suite of Drug Metabolism and Pharmacokinetics (DMPK) services.
Pharmacokinetics
At Synergy Bioscience, our pharmacokinetics (PK) services are a cornerstone of the drug development process, providing crucial insights into the safety and efficacy of therapeutics.
Pharmacodynamics
Synergy Bioscience is at the forefront of pharmacodynamics (PD) studies, playing a pivotal role in the early stages of drug development.
Biomarkers
At Synergy Bioscience, we recognize that biomarker analysis is a pivotal component in the drug development process, providing essential insights into a therapeutic’s efficacy, safety, and mechanism of action.
Immunogenicity
Synergy Bioscience stands as a bastion of safety and efficacy in the realm of therapeutic development, particularly through our unmatched expertise in immunogenicity risk assessment.
CMC Bioanalytical
In the intricate landscape of drug development, Synergy Bioscience stands as a beacon of excellence in CMC bioanalytical testing. Recognized for our meticulous approach, we ensure that each pharmaceutical product adheres to the highest standards of safety, efficacy, and quality.