A Marketing Authorisation Application (MAA) is the formal submission required to obtain approval to place a medicinal product on the EU market. RBridge Lifesciences supports pharmaceutical companies through the full MAA lifecycle — from gap assessment and dossier compilation through to agency liaisoning and post-approval maintenance.
What We Offer
- Gap Assessment and Dossier Preparation
- Agency Liaisoning
- GMP Inspection Support via NPRA
- ACTD Dossier Preparation
- Marketing Authorisation Maintenance
- Support for Centralised, Decentralised, and Mutual Recognition Procedures
Key Considerations
- EU MAA submissions follow the Common Technical Document (CTD) format
- Centralised procedure (EMA) covers new active substances, biologics, and certain generics
- Decentralised and Mutual Recognition Procedures used for simultaneous multi-country submissions
- Post-approval lifecycle management is an ongoing regulatory obligation