- Scientific Advice or Protocol
- Filing strategy EU (National, MRP, DCP, Centralised, Abridged applications)
- Filing strategy US (NDA, BLA, ANDA)
- Pre-submission agency meetings
- GMP Audits; Validation requirements; TPM sites identified
- EU / US DMF preparation and submission; CEP applications ; VAMF applications ; SMF preparation
-
Dossier preparation
– Module 1 (regional model, SmPC preparation, Artwork,
Braille requirements, PIL preparation and
PIL User testing, ERA)
– Module 2-5 (expert assistance where required)
- Intelligence gathering
