DossiAIr supports agency-specific formatting, templates, and regulatory requirements for FDA, EMA, PMDA, NMPA, Health Canada, TGA, MHRA, and other global authorities. Generate compliant eCTD submissions tailored to each agency's unique standards.
Full support for the world's leading pharmaceutical regulatory agencies
World's most influential regulatory agency with rigorous standards for NDA, BLA, and ANDA submissions.
Centralized procedure for marketing authorization across all EU member states, Iceland, Liechtenstein, and Norway.
Japanese regulatory authority requiring bilingual submissions and unique CMC requirements for pharmaceutical approvals.
Chinese regulatory authority with rapidly evolving requirements and increasing alignment with ICH guidelines.
Canadian regulatory authority requiring bilingual (English/French) labeling and eCTD submissions aligned with ICH.
Australian regulatory authority with streamlined pathways for products already approved by FDA, EMA, or other reference agencies.
UK regulatory authority post-Brexit with new pathways independent of EMA while maintaining high scientific standards.
Swiss regulatory authority with high scientific standards and streamlined procedures for products approved by reference agencies.
Support for regulatory agencies across all major pharmaceutical markets
Built-in knowledge of unique requirements for each regulatory authority
Agency-specific Module 1 generation with correct forms, cover letters, and administrative documents.
Multi-language document generation and translation for international submissions.
Compliance with agency-specific data format requirements and standards.
Export formats compatible with each agency's electronic submission gateway.
3,400+ agency-specific regulatory prompts ensure compliance with local guidelines.
Pre-submission validation against agency-specific technical specifications.
See how DossiAIr can generate agency-compliant submissions for FDA, EMA, PMDA, and other global authorities.