Regulatory Services | Sana Pharma
Regulatory Services
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    Sana Pharma offers group of regulatory services such as:

    • CTD files preparation and review.
    • Response to deficiency letters.
    • Monitoring and auditing bioequivalence studies.
    • File registration and follow up.
    • GMP consultation (site layout, documentation system training.
    • Patent check and “free to operate opinion” in KSA.

Sana Pharma also provides

  • Technical opinion concerning the registrability of products or manufacturing sites through the review of the product dossiers, Drug Master Files, Site Master Files.
  • Expert reports for clinical and none clinical studies and summaries (CTD modulesII, IV & V).
  • Periodic safety update reports (PSUR).
  • Our qualified experts are ready to work as independent party for inspection of API’s
  • or pharmaceutical manufacturing sites for regulatory purposes.