X Pharma Plus delivers expert gap analysis services to identify and resolve regulatory gaps, ensuring compliance and accelerating product approvals.
Regulatory Compliance and
Gap Analysis – Overview
Regulatory compliance and gap analysis are essential for the successful registration of medicinal products. While most Health Authorities (HAs) accept applications in the CTD format, the content requirements for each section may vary. Conducting a thorough regulatory gap analysis and technical assessment of supporting documents helps manufacturers identify and address gaps before submission, reducing the risk of rejections and minimizing critical queries, thereby accelerating approvals.
Evaluating legacy dossiers against current manufacturing and regulatory practices ensures compliance and highlights areas requiring mitigation. Addressing these gaps proactively—through supplements or variations—prevents non-compliance issues. X Pharma Plus, with its experienced regulatory affairs and CMC experts, provides comprehensive regulatory gap analysis support to help sponsors achieve smooth, timely product approvals.
Regulatory Compliance and Gap Analysis
“A systematic review to ensure products meet regulatory requirements and identify areas needing improvement before submission.”