Services

Navigating the registration of medicinal products in Tajikistan requires deep knowledge of the Law "On Medicines and Pharmaceutical Activities." We provide end-to-end support for new drug applications, ensuring your dossier meets the specific National Format requirements of the SSSHSPP (State Supervision Service).

• Dossier Development: Compilation of administrative, quality, and clinical data in Russian or Tajik.

• Expertise Management: We act as your liaison during the primary and specialized expert examinations.

• Sample Logistics: Coordination of sample delivery for mandatory laboratory testing in local state-accredited labs.

• Renewals & Variations: Timely submission for 5-year certificate renewals and management of post-approval changes (dosages, packaging, or manufacturing sites).

From Class I consumables to Class III high-risk diagnostic equipment, we ensure your medical devices are legally compliant and ready for the Tajik healthcare market. The registration process typically spans 2 to 6 months, and we accelerate this by ensuring documentation is "right first time."

• Classification Guidance: Correct categorization of your device under Order No. 736 to determine the required clinical data.

• User Documentation: Professional translation of user manuals and technical files into Tajik and Russian.

• Import Permits: Facilitating the mandatory single-use or annual permits required for customs clearance.

• Clinical Evaluation: Support in gathering and presenting local or international clinical evidence for specialized review.

The market for dietary supplements and BAAs in Tajikistan is governed by strict food safety and therapeutic claim regulations. We simplify the complex intersection of the Ministry of Health and the Agency for Standardization (Tajikstandard).

• Ingredient Review: Pre-submission analysis of your formula to ensure all components are permitted under Tajik law.

• Hygienic Certification: Securing the necessary safety protocols and toxicological reports for your product.

• Label Compliance: Reviewing packaging and instructions to ensure no unauthorized therapeutic claims are made, preventing costly customs delays.

• 5-Year Authorization: Securing a Registration Certificate valid for half a decade of market access.

Foreign manufacturers often require a Local Representative to hold the Marketing Authorization (MAH) and interface with health authorities. We provide the infrastructure and licensed personnel to satisfy these legal mandates.

• Marketing Authorization Holder (MAH): Serving as your legal entity in Tajikistan for all regulatory and administrative purposes.

• Local Person for Pharmacovigilance (LPPV): Our licensed experts provide 24/7 monitoring and reporting of adverse events, fulfilling mandatory post-market safety requirements.

• Customs & Distribution Support: Utilizing our local presence to assist in the smooth transit of pharmaceutical goods through the Dushanbe customs post.

• Regulatory Intelligence: Real-time updates on changes in Tajik pharmaceutical laws and state fee structures.