A complete, well-compiled regulatory dossier is the foundation of any successful product registration. RBridge Lifesciences provides end-to-end dossier compilation services, ensuring that all modules are complete, accurate, and aligned with the requirements of the target health authority.
What We Offer
- Gap Assessment of existing documentation against target market requirements
- Dossier Compilation in CTD, ACTD, and country-specific formats
- Dossier Review and Quality Check
- Coordination of technical sections (pharmaceutical, non-clinical, clinical)
- Regulatory writing and compilation of Module 1 administrative documents
- Preparation of cover letters and application forms
Dossier Formats Covered
- CTD (Common Technical Document) – ICH M4 format
- ACTD (ASEAN Common Technical Dossier)
- Country-specific formats for non-CTD markets
- eCTD (electronic CTD) compliant structure