Overview
In many regions, marketing authorizations are not perpetual. We track your renewal dates and manage the renewal application process, ensuring you provide the necessary benefit-risk re-evaluation data to keep your product on the market without interruption.
Key Features
Renewal timeline tracking
Benefit-risk re-evaluation
Renewal dossier preparation
Agency communication
Our Process
1
Planning
Identifying renewal windows years in advance.
2
Compilation
Gathering the 5-year data package.
3
Submission
Filing the renewal application.
Project Complete & Deliverables Provided
Frequently Asked Questions
No. Unlike many other countries, US NDA/BLA approvals are granted indefinitely—they don't require periodic renewal. However, you must maintain compliance through annual reports, safety reporting, and keeping your facilities in good standing. FDA can withdraw approval if you violate regulations, but there's no automatic expiration date requiring renewal applications.
Why Choose Us
- Uninterrupted sales
- Regulatory good standing
- Strategic portfolio management
- Reduced administrative burden
Get More Details
Request a personalized consultation and detailed information about this service.
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Contact our team to discuss your specific needs for License Renewals.
Schedule ConsultationWhat Our Clients Say
"We acquired a company with 15 marketed products across 60 countries. License renewal tracking was a nightmare. Adelphi built us a comprehensive renewal database, caught 3 products that were about to lapse, and now manages all our renewals proactively."
Steven Richards
Head of Regulatory Operations
Global Pharma
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