- A white paper from Synomics Pharma, titled “BioAnalytical Quality Standard Initiative — Implementing ICH Q10 for Clinical Trials”, describes the BQSI, an initiative born out of the industry-wide recognition that neither the US FDA or EMEA regulation nor ICH harmonized guidelines address laboratory analysis in support of clinical trials. To download the paper and the latest version of the Bioanalytical Quality Standards Initiative (BQSI) Guidance Document,
- A new white paper from Synomics Pharma, titled "Developing and Validating Dissolution Procedures for Improved Product Quality", discusses specific method validation guidelines used in developing and validating dissolution test procedures.
Click to download the white paper.
- Download the new white paper:
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LATEST NEWS & EVENTS
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- Synomics Pharma and BioScience Laboratories, Inc. announced a formal partnership to provide fully integrated study services for trials in healthy human subjects. .
- Dr. Michael Swartz, Director of Research and Development at Synomics, contributed a chapter on Method Validation in the newly published Introduction to Modern Liquid Chromatography, 3rd edition. This latest edition of the authoritative reference to HPLC offers the most up-to-date, comprehensive, and accessible survey of methods and applications available.
- In the inaugural installment of his new column, LCGC veteran, Dr. Swartz, provides an overview of some of the newer LC technology used in contemporary LC laboratories in a new column:
- - Making Complex HPLC Analyses Simple for a Wide Spectrum of Analytes: Ions, Surfactants, Polymers, Biofuel, featuring Dr. Swartz, presented by LCGC magazine.
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| Superior Quality and Value in Pre-Clinical and Clinical Bioanalytical Testing and Drug Development Services |
Synomics Pharma provides high-quality, client-specific drug testing solutions by rapidly delivering effective and robust analytical and bioanalytical services, accompanied by clear, concise, and timely communication.
As a leading global pharmaceutical Contract Research Organization (CRO), we specialize in customized pre-clinical and clinical bioanalytical services, analytical chemistry services, and stability studies. Synomics Pharma offers a number of progressive analytical chemistry technologies, such as Charged Aerosol Detection and dissolution testing. Our bioanalytical expertise includes bioanalysis of controlled substances sugars, lipids, and complex vitamins, we handle all ICH (long-term, short-term, and accelerated) stability studies for preclinical, clinical, and commercial projects.
Through the Bioanalytical Quality Standards Initiative, BSQI, Synomics is leading the way to developing documented quality management standards for bioanalysis testing in support of clinical trials. As members of the GPHA, we provide unique bioanalytical and analytical testing services to support manufacturers and distributors throughout the generic and pharmaceutical industry. We are also a recognized Central Contract Registration (CCR) service provider for government institutions. Our sister company, SP Formulations, co-located at our Massachusetts facility, delivers a broad range of formulations services for small and large molecules in a variety of pharmaceutical dosage forms including liquids and semisolids.
With a globally-recognized quality management system, and a team of experts committed your complete product lifecycle, Synomics Pharma provides superior service, from discovery through drug development. |
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