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Compliance • Strategy • Market Entry
We manage the full product lifecycle — from pre-registration to post-marketing surveillance — ensuring smooth and compliant market access.
Key Expertise:
- Regulatory strategy & dossier preparation (CTD/eCTD).
- Submissions & follow-up with MOHAP, SFDA, NHRA, etc.
- Labeling, packaging & artwork compliance.
- Product renewals, variations & amendments.
- Pharmacovigilance & risk-management systems.