Post-Approval Submissions: Supplements, Variations, and Annual Reports

Regulatory Operations Services

Post-Approval Gap Analysis

Comprehensive Gap Analysis to Support Regulatory Compliance Throughout the Product Lifecycle

Getting marketing approval is just the start. Staying compliant with post-approval changes like variations, supplements, and annual reports is essential to keep your product on the market.

At Techsol Life Sciences, we provide tailored Gap Analysis Services for post-approval submissions, helping you stay ahead of regulatory changes. From manufacturing updates and safety data to labeling revisions, we ensure your documentation stays accurate and compliant across global markets.

Scope of Our Post-Approval Gap Analysis Services

Our team evaluates the completeness, regulatory conformance, and technical accuracy of post-approval documentation to ensure readiness for submission across different regulatory pathways:

U.S. FDA - Supplements & Annual Reports

We conduct gap assessments for:

CBER/CDER Supplements (CBE-0, CBE-30, Prior Approval Supplements)
Annual Reports for NDAs, BLAs, and ANDAs

Gap Review Focus Areas:

Verification of change classification per FDA guidance
Evaluation of CMC updates, manufacturing site changes, and labeling revisions
Review of stability data, batch release testing, and comparability data
Assessment of adverse event summaries and PSUR/PBRER alignment
Documentation completeness for Form FDA 356h, cover letters, and summary tables

EU and Global - Variations & Lifecycle Maintenance

For the European Union and other ICH regions, we assess documentation for:

Type IA, Type IB, and Type II Variations
Work sharing Procedures and Grouped Submissions
Renewals and PSUR submissions

Gap Review Focus Areas:

Correct classification of variation type per EU Variation Regulation (EC No 1234/2008)
Conformance with EMA/CMDh procedural templates and timelines
Labeling updates and product information (SmPC, PIL, labeling mock-ups)
Justifications for quality changes (e.g., manufacturing process, specifications)
Assessment of bridging data, prior commitments, and variation history

Annual Safety and Performance Updates

Gap assessment of Periodic Benefit-Risk Evaluation Reports (PBRERs)
Review of PSUR/ASR submissions as per region-specific timelines
Evaluation of benefit-risk narrative, new safety signals, and cumulative data analysis