Main Achievements

• Participation to worlwide submissions: > 20 drugs in 40 countries (US, EU, LATAM, Asia, MENA, etc)

• Setting the CMC regulatory strategy

• Preparing CMC parts of dossiers

• Managing answer strategy to questions from health authorities

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• Participation to meetings with:

  • Health Authorities: FDA (2), ANVISA (2)

  • Pharmacopeias: Ph. Eur. and USP

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• Elaboration of a monographs with:

  • Ph. Eur.: for a drug substance

  • USP: for 2 drug products

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• Set tools to facilitate: 

  • Gap analysis

  • Authoring/Updates of dossiers

  • Handling of  Q&A from authorities