Regulatory Life Cycle Management & Post-Approval Activities
Maven’s Center of Excellence supports regulatory life cycle management and post-approval activities across industries. We help manufacturers navigate changes to registered content and maintain compliance throughout the product’s life span.
Post-Approval Changes
After product approval or during commercialization, manufacturers may propose administrative or quality changes to the dossier. These are submitted as supplements, variations, or amendments to the relevant health authority.
Life Cycle Management Responsibilities
Marketing Authorization Holders (MAHs) must keep dossiers updated per regional requirements. This includes post-approval changes, annual reports, and renewals. Regulatory strategy is key to timely approvals and acceptance.
Post-Approval Services
- Manufacturing site changes
- MAH transfers
- Process optimization
- Formulation changes
- Batch size adjustments
- Supplier additions for active substances
- New sources for starting materials
- Route of synthesis changes
- CEP updates and new CEPs
- Equipment/instrument changes
- Analytical method updates
- Container closure system changes
- Primary packaging supplier changes
- Shelf life extensions or reductions
- eCTD/CTD dossier preparation
- Drug license renewals
- Re-registration dossiers
Additional Capabilities
- Centralized Dossier Preparation
- Publishing & Submissions
- Regulatory Information Management
- CMC & Change Control
- Labeling & Artwork functions
- Health authority query responses
- “First Time Right” strategy implementation
