Global Product Approval & Management

• End-to-end support for regulatory submissions in CTD, eCTD, and ACTD formats, tailored to global agency requirements.

• Experience with drug products, APIs, semi-finished formulations, and complex dosage forms.

• Management of lifecycle activities including renewals, post-approval changes, and regulatory variations.

• Dossier gap analysis, remediation, and global strategy planning to accelerate approvals.

• Ongoing compliance monitoring to maintain marketing authorization in multiple regions.