DossiAIr supports agency-specific formatting, templates, and regulatory requirements for 27 global authorities including FDA, EMA, PMDA, NMPA, Health Canada, TGA, SAHPRA, MHRA, CDSCO, COFEPRIS, and more. 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.
South African regulatory authority with Climatic Zone IVB requirements and unique local compliance needs.
UK regulatory authority post-Brexit with new pathways independent of EMA while maintaining high scientific standards.
Beyond major markets, DossiAIr provides regulatory prompts and compliance support for emerging pharmaceutical markets worldwide
Each agency has dedicated regulatory prompts covering local requirements, language needs, stability zones, and regional compliance standards. Prompts are continuously updated as guidelines change.
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.