Overview
Change is constant. Whether it's a new manufacturing site, a process improvement, or a supplier change, we determine the appropriate reporting category (CBE-0, CBE-30, PAS, Type IA/IB/II) and manage the submission to ensure your supply chain remains uninterrupted.
Key Features
Change control regulatory assessment
Variation/Supplement preparation
Comparability protocol design
Global variation management
Our Process
1
Assessment
Reviewing the change and determining the filing strategy.
2
Compilation
Gathering data and writing the supplement.
3
Submission
Filing and managing approval.
Project Complete & Deliverables Provided
Frequently Asked Questions
These are the four FDA reporting categories for post-approval changes under 21 CFR 314.70. PAS (Prior Approval Supplement) is for major changes requiring FDA approval before implementation. CBE-30 means you can implement 30 days after submission unless FDA objects. CBE-0 allows immediate implementation with concurrent notification. Annual Report is for minor changes reported once yearly. The category depends on the change's potential to affect product quality, safety, or efficacy.
Why Choose Us
- Supply chain continuity
- Compliance with reporting rules
- Operational flexibility
- Reduced regulatory burden
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Schedule ConsultationWhat Our Clients Say
"We had 12 post-approval changes pending across multiple products. Adelphi assessed each one, identified 3 that could be CBE-0 instead of CBE-30, and developed a comparability protocol that streamlined future changes. Our regulatory burden dropped significantly."
Linda Martinez
Director Regulatory CMC
Generic Pharma
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