Preparation and publishing of:

• Amendments (e.g., protocol changes, clinical trial updates)
• Supplements (e.g., labeling changes, CMC updates)
• Variations (Type IA, IB, II for EU MAA, SmPC updates, administrative changes)
• Annual reports, PSURs, and renewals

Coordinated support for product changes across multiple markets with regulatory impact assessments and aligned submission strategies.

Assessing regulatory impact of changes (e.g., manufacturing site changes, packaging updates, formulation modifications) and advising on appropriate submission pathways.

Publishing submission updates in eCTD/NeeS/paper formats in compliance with region-specific guidelines (FDA, EMA, Health Canada, TGA, etc.).

Use of validated systems for document versioning, sequence tracking, and correspondence archiving to ensure traceability and audit readiness.

Managing communications and queries from regulatory authorities related to post-approval submissions.