Pharmaceutical Product Registration

Full-scope CTD dossier compilation, submission, national & EAEU registration, and post-approval variations.

Registration Pathways in Kazakhstan & EAEU

Under EEC Council Decision No. 78, pharmaceutical manufacturers can register products via national procedures or unified EAEU supranational routes.

MANSAR Medical provides full-cycle regulatory support for pharmaceutical product registration.

  • check_circle New product registration
  • check_circle EAEU registration procedures
  • check_circle National registration procedures
  • check_circle Registration recognition procedures
  • check_circle Registration dossier preparation and review
  • check_circle Preparation of responses to regulatory authority questions
  • check_circle Regulatory strategy development

CTD / eCTD Dossier Preparation

Our medical writing experts compile and review all 5 CTD Modules to ensure 100% submission compliance.

Module 1 Administrative Information & Prescribing Information
Module 2 Common Technical Document Summaries
Module 3 Quality (Chemical, Pharmaceutical & Biological Data)
Module 4 & 5 Nonclinical Study Reports & Clinical Study Reports

Ready to Enter Kazakhstan & EAEU Markets?

Let our regulatory experts guide your product through every step of the registration and compliance process. Reach out today for a no-obligation consultation.

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