Key Deliverables
Comprehensive support tailored to your specific regulatory needs.
Post-Market Variations
Management of changes to your approved product (CMC, labeling, etc.) through Supplements, Amendments, and Variations.
Annual Reports (PADER/PSUR)
Timely preparation and submission of mandatory periodic safety and status reports to maintain compliance.
Labeling Updates
Strategic management of labeling changes, including CCDS updates and negotiation with health authorities.
Safety Reporting
Ongoing pharmacovigilance support, including adverse event reporting and safety signal management.
License Renewals
Tracking and management of marketing authorization renewals to ensure uninterrupted market access.
Our Approach
A proven methodology designed to minimize risk and maximize speed to market.
Compliance Monitoring
We continuously monitor your product's regulatory status and upcoming deadlines to prevent compliance lapses.
Change Control
We assess the regulatory impact of proposed manufacturing or labeling changes to determine the appropriate filing strategy.
Efficiency Optimization
We streamline your post-market maintenance activities to reduce burden and cost while maintaining robust compliance.
Commercial Alignment
We align regulatory activities with commercial goals, supporting line extensions and new indications to maximize product value.
Ready to Accelerate Your Regulatory Success?
Contact us today to discuss your specific needs and how we can support your goals.