Regulatory Affairs
Global Regulatory Excellence
Ensuring seamless registration and compliance across global markets
Alkem Activa's Regulatory Affairs team provides comprehensive CTD/eCTD dossier support, DMF filings, and regulatory maintenance worldwide.
Comprehensive Filings
Extensive portfolio of US DMFs, CEPs, EU DMFs, and JDMFs supporting generic formulation launches.
Regulatory Milestones & Filings
2020US DMF & CEP Filings
- Achieved key US FDA DMF filings and CEP certifications for core APIs.
2022Global Market Expansions
- Expanded DMF submissions across Japan (JDMF), China, and Brazil (ANVISA).
* All regulatory filings are maintained with up-to-date annual reports and CEP revisions.
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