CMC Regulatory support

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

  • Scientific writing of regulatory documentsĀ : ASMF, DMF, CEP, IND, IMPD, MAA and NDA / BLA module 3, writing of responses to agency questions.
  • CMC regulatory strategy and meetings with health authorities
  • Geographical roll out
Medical prescription Pharmaceutical drug