Authoring and Review of CMC dossiers - Services Examples

person using laptop
person using laptop
Development

  • Compilation of documentation, authoring and review of EU Investigational Medicinal Product Dossier (IMPD), US Investigational New Drug Application (IND) and International Clinical trial Application (CTA)

  • Briefing documents for Authority consultation (US FDA Type C/B meetings, EU EMA Scientific Advice consultation, Canadian BGTD Scientific Advice)

Licensing

  • CMC Module 3, Module 2.3 for dossier licensing (US, EU, Japan, Canada, International countries)

  • Non-Clinical Module 4 and Module 2.4 & 2.6 for dossier licensing (US, EU, International countries) for a recombinant vaccine

  • Briefing documents for Authority consultation prior to licensing (US FDA pre-BLA meeting, EU EMA Scientific Advice consultation, Canadian BGTD Scientific Advice)

Post-Approval

  • Compilation of documentation, authoring and review of post Approval variations/supplements (US, EU, International countries), including Scope & Background Summary documents

  • Briefing documents for Authority consultation prior to filing of major variations or for communication of post-approval issue & management.

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