Importers · Market authorisation applicants
Dossiers & Regulatory Support
Product registration in a new market lives or dies on documentation. We assist with CTD/eCTD dossier coordination, stability study data and BA/BE documentation through our manufacturing partners — aligned to the target authority's requirements.
What we support
- CTD / eCTD dossier coordination from manufacturing partners
- Stability study data (accelerated and long-term) where available
- BA/BE study documentation support
- Authority-specific format guidance (ACTD, CTD, country variations)
- Gap assessment before you commit to a registration file
How the request works
- 1. Requirement Assessment
Target country, product and the authority's current requirements.
- 2. Gap Analysis
What documentation exists with the manufacturer vs what the authority needs.
- 3. Dossier Coordination
Compilation and formatting support through the manufacturing partner.
- 4. Submission Support
Response coordination for authority queries during review.