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)
Licensing
CMC Module 3, Module 2.3 for dossier licensing (US, EU, Asia, International countries)
Briefing documents for Authority consultation prior to licensing (US FDA pre-BLA meeting, EU EMA Scientific Advice consultation.
