Post-Approval Regulatory Affairs

End-to-end lifecycle management services that support regulatory compliance following product approval. The offering enables efficient management of post-approval changes through strategic planning, submission execution, publishing, and coordination across global and local markets while ensuring continued regulatory compliance. Lifecycle Submission Management – Global lifecycle management – Variation management (IA/IB/II, CBE, PAS, etc.) – Renewals – Annual reports – Change management – CMC lifecycle management – Line extensions – Product transfers – Marketing authorization transfers – Withdrawal submissions Regulatory Operations & Compliance – Health authority query responses – Submission management – eCTD publishing – Regulatory publishing QC – Regulatory data management – RIMS support – Commitment tracking – Global coordination – Regulatory metrics and reporting