Country Dossier Checklist
Living, country-specific dossier checklists for CTD, ACTD, and Module 1 requirements across emerging markets.
The problem it solves
Every destination market wants its dossier assembled differently — a CoPP here, a local technical representative authorization there — and that knowledge usually lives in one regulatory affairs person's head or a folder of old submissions, not a checklist anyone else can run from.
How it works
- 1Start from a seeded checklist for a market already in the library (India/CDSCO, the Philippines/FDA, Kenya/PPB, the UAE/MOHAP, and Brazil/ANVISA today).
- 2Track each required document against the checklist — module/part label, document type, and whether it's time-bound.
- 3Log a submission against the checklist so the team can see what's outstanding for a given product/market pair.
Who it’s for
Regulatory affairs staff handling emerging-market product registration.
What if our target market isn't in the library yet?
The library is a working starting set, not a finished map of every market — five markets are seeded today, with more added as they're built out. Ask about adding a specific market before assuming it's covered.