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.

Outcome: Faster registration, sustained compliance, and trusted authority relationships.

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