• 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, click here.
  
  
• 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 here to download the white paper.
  
  
• Download the new white paper: An Overview of Corona Charged Aerosol Detection in Pharmaceutical Analysis

LATEST NEWS & EVENTS

• Dr. Michael Swartz will speak on Forced Degradation Studies at the Southern California Pharmaceutical Discussion Group (SCPDG) on April 8, 2010. Click here to join the SCPDG.
  
  
• Dr. Kirk Smith will present on Bioanalytical Quality Standards Initiative (BQSI) to major Worldwide Regulatory Agencies at the 4th Regulated Bioanalysis Workshop, in Montreal on April 21-23 2010.
  
  
• Synomics Pharma will present poster sessions at the 58th ASMS Conference on Mass Spectrometry, May 23-27, in Salt Lake City. Adam Grenier will present on synovial fluid validation, and Larry Andrade will present on plasma validation.
  
  
• Visit Synomics in Boston at the Hynes Convention Center for the 35th International Symposium on High Performance Liquid Phase Separations, HPLC 2010, on June 19-24. Register here.
  
  
• The US patent office has approved Patent No. 7628920, Compositions and methods for separating enantiomers, an application developed by Dr. Michael Swartz for HPLC analytical chemistry. For more information about Synomics’ advanced analytical separation science offerings, contact info@synomicspharma.com.
  
  
• Live at PITTCON: MS/HYPHENATED Interviews: Click here to view the podcast featuring Dr. Michael Swartz.
  
  
• 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:
  INNOVATIONS IN HPLC Anatomy of a Contemporary LC System.
  
  
• Register to view the free webcast - Making Complex HPLC Analyses Simple for a Wide Spectrum of Analytes: Ions, Surfactants, Polymers, Biofuel, featuring Dr. Swartz, presented by LCGC magazine.
  

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.