As a distinguished Contract Research Organization (CRO), we excel in providing analytical chemistry and microbiology testing, comprehensive product development support, and adept quality compliance consulting services. Our commitment to scientific excellence and cutting-edge technical capabilities ensures a seamless transition of your product from concept to market. Synergy Bioscience is not just a service provider; we are your strategic partner, guiding your product journey toward triumphant outcomes.
Proudly, we are a GLP/GMP FDA-registered facility, emphasizing our adherence to the strictest quality standards in the industry. Our DEA License and CLIA Certification underscore our dedication to regulatory compliance and operational excellence. Furthermore, our ISO 17025 Certification demonstrates our unwavering commitment to quality, precision, and reliability in laboratory testing. Trust Synergy Bioscience to be the catalyst for your vision, ensuring that every milestone is met with rigor, precision, and success.
Analytical Chemistry
We specialize in testing drug products, drug substances, and nearly all dosage forms including tablets, capsules, semi-solids, sterile, transdermal, and inhalation products. Our mission it to provide you with analytical solutions that will make achieving your drug development goals easier and faster.
Microbiology Testing
We prioritize quality, safety, and compliance in all our microbiology testing services. Our work ensures the integrity of your manufacturing process and helps uphold the highest industry standards.
Pharmaceutical Development
Our pharmaceutical R&D activities span the development continuum from preclinical through post-approval and are customized to address specific development challenges of small molecules and biologics, vaccines, medical devices and companion diagnostics.
Clinical Research
Our clinical research and development team has extensive experience across various therapeutic modalities. We offer tailored solutions that meet the specific needs of your project, ensuring regulatory compliance and a seamless transition between clinical trial phases. Our comprehensive capabilities ensure that from the first-in-human trials to post-market surveillance, your clinical endeavors are in expert hands.
Consulting (Quality System Compliance)
Most organizations neither have the time, staff, or the resources to keep up with the often subtle changes in regulatory requirements and guidelines, and rely on the expertise of Quality System consultants to ward off troubles. Synergy Bioscience is the leading source of assistance for any issue related to Quality Systems. We listen closely and develop a quality system tailored to your company’s specific needs.
At Synergy Bioscience, we challenge ourselves to a higher standard — a global standard, using global practices to reach global markets.
Achieving that level of excellence begins with listening intently to your issues and designing strategies rooted in our experience to guide you through the regulatory complexities and provide successful results.
What We Offer
With Synergy Bioscience you get more than good services. You get Quality services you can truly rely on and trust. From early product development and a full scale laboratory testing support, our scientific experts are uniquely qualified to navigate your unique journey, every step of the way. In addition, Synergy Bioscience makes sure that all your quality solutions are implemented properly, with one-on-one coaching for your key staff members.
Our Services
Past Projects
In Pursuit of Excellence: Recent Extractable/Leachable Study
The primary goal was to conduct a comprehensive E&L analysis to confirm the safety of API concentrates when stored in these medical grade bags. ....
THE DEVELOPMENT OF AN INHALATION DRUG PRODUCT
Showcasing one of our recent venture into developing an inhalation drug product: Sumatriptan. ....
FOSTERING INNOVATION IN ANTIBACTERIAL THERAPIES
This journey reveals our collaboration with a client aimed at developing a generic drug to address ....
Synergy Bioscience and the Art of Overcoming Challenges
We are spotlighting our involvement in the development of an aminoglycoside antibiotic for severe bacterial ....
Unveiling the Potential of Innovative Drug Development with Synergy Bioscience
One of our most recent achievement showcases our ability to accelerate drug product development...
Batch Record Reviews
After receiving an FDA Warning Letter, a well-known pharmaceutical company requested from Synergy to get involved in the remediation of their warning letter.
Chemistry Lab Operation
A CRO/CMO pharmaceutical start up requested from Synergy to help with the set up and initial operation of their chemistry laboratory to support in the development
Cleaning Validation
As part of their cGMP facility operation readiness, a client of ours requested that we develop and validate a cleaning validation program to support their development
Bio Process Validation
A biopharmaceutical company requested from Synergy to work with their engineering department and help in the optimization and revalidation of their manufacturing process
cGMP Facility Transfer
A medical device company, developer and manufacturer of implantable class III medical devices, hired us to help in one of their cGMP facilities transfer.
Supplier Quality Audit
A well-known biotechnology company requested from Synergy to review and improve their Supplier Quality Management system.
CAPA Process
A well know medical devices company was under Consent Decree and in desperate need of special expertise to help them get out of it sooner so they can resume their business.
Our Clients
