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Literature / Brochures

Clinical Development

Syngene supports early-phase to late-phase clinical trials required for drug development programs across a wide range of therapeutic areas.

Released By Syngene International Ltd.

Capabilities

BA/BE Studies to Support Development of Generic Drugs 

  • Over 150+ validated methods available as per USFDA guidelines
  • Total Mass Specs: 10 [API 4000s and API 6500s]
  • State-of-the-art instrumentation [with qualification]
  • Analysis of drug(S) and/or metabolite(s) in biological specimen [e.g. blood, plasma, serum etc.] to support TK< PK, early phase clinical development, BA/BE and TDM studies
  • Team of 40 qualified and experienced researchers with experience in method development, validation and regulated Bioanalysis for a wide range of chemically diverse drug molecules
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