Marketing Authorization

Achieving Marketing Authorization with Confidence
Statim Ltd guides you through the final steps to bring your product to market with confidence. Our team’s deep understanding of the EMA and MHRA processes ensures that your Marketing Authorization Application (MAA) is complete, compliant, and ready for approval.

Our Marketing Authorization Services:

  • MAA Preparation and Submission: Comprehensive management of the MAA process from start to finish.
  • Labeling and Packaging Compliance: Ensuring all product labeling meets regulatory standards for clarity and compliance.
  • Post-Market Authorization Support: Ongoing assistance with pharmacovigilance, variations, and renewals to maintain your product’s market authorization.
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