Marketing Authorisation Applications (MAA)
Regulatory Affairs
Obtaining marketing authorisation requires robust documentation and effective coordination with health authorities.
PVpharm provides end-to-end support for MAA procedures across multiples regions and regulatory pathways.
Our services include:
- MAA preparation: Preparation, compilation and review of submission dossiers
- Procedure management: Support for national, decentralized, mutual recognition, and centralized procedures
- Authority interactions: Coordination with health authorities throughout the review process
- Post-submission support: Management of regulatory questions and additional data requests
