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Integrated Discovery, Development  &

Regulatory Services

Chemistry Services/Solutions

CMC (Chemistry, Manufacturing & Controls) as a standalone service or as a part of IND package; complete support in drug development involving

  • Process development and optimization
  • Form selection (Polymorph's and/or salts screening)
  • Physiochemical studies
  • Material generation (Non-GMP) for non-clinical studies
  • Material generation (GMP) for Phase I & IIa  clinical trials
  • Method development and validation
  • Qualification of standards, Impurity profile
  • Forced degradation
  • Stability studies of API
  • Dossier (CMC) preparation and support in regulatory submissions

 

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