CMC Regulatory support

CMC Regulatory support : Interacting with authorities at every stage of development and generating associated CMC documentation

  • CMC regulatory strategy: Identify the scientific package needed at each development stage, Check the consistency between available data & Regulatory requirements, Perform CMC gap analysis
  • Interaction with Health Authorities (EU/US/Export)
  • Geographical roll out
  • CMC variations
  • Scientific writing of regulatory documents : ASMF, DMF, CEP, IND, IMPD, MAA and NDA / BLA module 3, writing of responses to agency questions.

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