Overview
Maintaining your license requires diligent reporting. We handle the preparation and submission of Annual Reports, PADERs, PSURs/PBRERs, and DSURs. We ensure your safety and status reporting is accurate, timely, and compliant with all regional requirements.
Key Features
NDA/IND Annual Reports
PADER/PSUR/PBRER authorship
DSUR preparation
Submission calendaring
Our Process
1
Data Collection
Gathering clinical, CMC, and safety data.
2
Authorship
Drafting the report according to templates.
3
Submission
Timely filing to the agency.
Project Complete & Deliverables Provided
Frequently Asked Questions
Per 21 CFR 314.81, NDA Annual Reports must be submitted within 60 days of the anniversary of your US approval date. For example, if your NDA was approved on March 15, your annual report is due by May 14 each year. Missing this deadline is a compliance violation that can trigger FDA enforcement action.
Why Choose Us
- Avoidance of compliance penalties
- Transparent safety profile
- Resource offloading
- Peace of mind
Get More Details
Request a personalized consultation and detailed information about this service.
Personalized consultation
Detailed service information
Custom timeline & proposal
We'll respond within 24 hours
Ready to get started?
Contact our team to discuss your specific needs for Annual Reports (PADER/PSUR).
Schedule ConsultationWhat Our Clients Say
"With 8 marketed products across 40 countries, our annual reporting calendar was chaos. Adelphi built us a comprehensive tracking system and took over all periodic report preparation. We haven't had a late submission in 3 years."
Patricia Kim
Global Regulatory Operations
Specialty Pharma
Related Services
Explore other ways we can support your regulatory needs