Support for Marketing Authorisation Applications (MMA)
Clinical Safety
Navigating the complex regulatory landscape of Marketing Authorisation Applications (MAA) requires expert pharmacovigilance support to ensure timely and compliant submissions.
Effective safety data management and documentation are critical components of a successful MAA.
PVpharm supports pharmaceutical companies throughout the pharmacovigilance components of the MAA process.
Our services include:
- MAA dossiers support: Preparation and review of pharmacovigilance-related sections for MAA dossiers
- Benefit-risk assessments management: Compilation and analysis of safety data to support benefit-risk assessments
- RMP management: Development and submission of RMPs aligned with regulatory expectations
- Regulatory Authorities requests: Coordination with Regulatory Authorities to address queries and provide additional safety information
