Marketing Authorisation Application (MAA)
Secure commercial approval for your drugs, biologics, and devices in global markets.
Complete Marketing Approval Management for Life Sciences
Obtaining a Marketing Authorisation (MA) is the final, most crucial hurdle in a pharmaceutical product's commercialization journey. At ADMFES, we manage the entire MAA compilation, validation, filing, and follow-up activities. We are recognized as the best provider for marketing authorisation application (MAA) services, working closely with pharmaceutical, biotech, and generic sponsors to secure prompt drug sales clearance.
Our capabilities cover the Centralised Procedure (CP), Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), and national approval pathways in European, Asian, Middle Eastern, and Latin American territories.
The Best Provider for MAA Submissions
From pre-filing strategies to national phase conversions, we coordinate every step of your marketing authorisation.
Our Comprehensive MAA Capabilities
We manage the entire lifecycle of Marketing Authorisation Applications, including:
Registration Procedure Strategy
Determine the optimal filing pathway: Centralised, DCP, MRP, or national registration filings.
Product Information Formatting
Drafting and localizing SmPCs, patient leaflets, and product label mockups in regional languages.
Variation and Post-Approval Support
Handle Type Ia, Ib, and Type II variations, renewals, and regulatory notifications smoothly.
National Phase Liaison
Coordinate translation and submission filings during national phases following MRP/DCP completions.
Optimize Commercial Launch Timelines
Every month of delay in MA approval translates to substantial lost commercial revenue. By implementing predictive project tracking and direct communication channels with lead reviewers, ADMFES helps you launch therapeutics ahead of competitors with minimal compliance risks.
Start Your MAA Path
Provide your molecule type and target regions for an estimated MAA roadmap.
Regulatory Services
- Regulatory Consulting
- Dossier Preparation & Compilation
- Due Diligence (Pre assessment)
- Gap Analysis
- Health Authority Communication
- Marketing Authorisation (MAA)
- FSSAI & Cosmetic Registration
- Medical Device Registration
- CDSCO India Registration
- Import License Application
- Indian Authorised Agent (IAA)