Coordinated with regulatory affairs
Application narratives are drafted against the same submission timeline regulatory affairs is managing, so nothing is written twice.
What's included
What goes into the submission package
- Narrative sections of the application drafted to the target health authority's required structure and terminology
- Cover letters, cross-reference tables, and administrative documents prepared alongside the scientific content
- Consistency check across the protocol, IB, and application narrative so the submission tells one coherent story
- Document formatting aligned to the eCTD or regional equivalent structure the submission will use
- Response drafting support for health authority questions raised during initial review
Consistent across the document set
When safety data changes mid-review, updates run through safety narrative writing and the reviewer's guide together, not in isolation.
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