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.