Coordination Activities

• For new products development and industrial transfer:

  • ​formulation

  • clinical batch production

  • analytical development

  • stability studies

  • packaging development

  • scaling up...

CMC Regulatory

• Define the content of dossiers

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• Write or review quality parts of dossiers for:

  • ​IND/IMPD​

  • DMF/CEP

  • NDA/BLA/CTD

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• Briefing packages

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• Investigator brochures

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• Answers to health authorities​

CMC Expertise

• Provide technical and CMC regulatory expertise throughout product development and in the framework of trouble shooting on already marketed products

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• Assess opportunities (due diligence)

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• CMC regulatory surveillance