🇹🇯 ValiPro: SSSHSPP, WHO GMP & National Dossier Validation Services

SSSHSPP-Aligned BA/BE & Comparative Dissolution Profiling Services — By BioEqui

Secure Product Registration in Tajikistan with Validation Documentation Aligned to National Requirements and International Standards.

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the Tajikistani market. Our documentation is built for full compliance with the rigorous standards enforced by the State Supervision Service for Health Care and Social Protection of the Population (SSSHSPP).

Key compliance pillars include adherence to international Good Manufacturing Practices (GMP), specifically the WHO Guidelines, and the submission of all quality data in the required National Dossier Format, translated into Russian or Tajik language.

🌟 Why SSSHSPP-Ready Validation is Crucial

Registration in Tajikistan requires a complete and organized set of documentation that proves the quality, efficacy, and safety of the product, with a specific focus on the manufacturing process.

• Mandatory GMP Evidence: Foreign manufacturing sites must provide a GMP Certificate (often accepted from WHO-recognized authorities or SRA-compliant countries). The SSSHSPP may, in rare cases, require an inspection of the manufacturing site. Robust process validation documentation is critical evidence to support this certificate and demonstrate process control.

• National Dossier Format: Unlike EAEU countries, the CTD (Common Technical Document) format is generally NOT accepted unless prior approval from the competent authority is obtained. The dossier must be submitted in the National Format and includes:

  • Quality Data: Composition, specifications, methods of control of the finished product, certificates of analysis, and stability data.

  • Manufacturing Information: A short description of the manufacturing process, which must be supported by comprehensive internal validation reports.

• Language Requirement: The registration dossier, including the summary of the manufacturing and quality data, must be submitted with a translation into the Russian or Tajik language.

• Analytical Testing: The submission requires samples of the medicinal product and reference standards. This implies that the validation of the analytical methods must be robust enough to be verified by the local control laboratory.

🎯 SSSHSPP Compliance Focus: Who We Support

We work closely with international manufacturers and their local representatives who need:

• Pharmaceutical Exporters: Targeting human and veterinary drug registration and renewal with the SSSHSPP.

• Language Adaptation: Companies requiring expert translation and presentation of complex technical validation summaries into Russian (the primary working language for technical documents).

• National Dossier Quality: Preparation of the quality sections to meet the SSSHSPP's technical expectations for the national format, ensuring easy review.

• Analytical Validation (AMV) Documentation: Providing validation reports for all control methods used for the drug substance and drug product, aligning with ICH Q2(R1) to support local testing requirements.

🛠️ Our Process Validation Services for Tajikistan

We provide complete, scientifically sound, and document-intensive support tailored to the content requirements of the Tajik National Dossier.

ServiceTajikistan / SSSHSPP FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO GMP principles, detailing the entire process and demonstrating control, ready for inclusion into the national dossier.National Dossier SummarizationStructuring the "short description of manufacturing process" and supporting quality data for the required format, focusing on completeness despite the limited space.Technical Translation SupportProviding accurate translation of validation summaries and key quality control data into Russian for the dossier submission.Analytical Validation DocumentationPreparation of AMV reports for all analytical methods (assay, dissolution, impurities) that must be verified during the registration process.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the SSSHSPP:

• WHO GMP Guidelines: The primary international benchmark for manufacturing practice compliance.

• Order of the Ministry of Health and Social Protection No. 736 (2015): The national procedure outlining the requirements for state registration of medicines.

• ICH Q2(R1) and Q7: Ensuring the validation of methods and APIs meets globally recognized standards.

🤝 Get Started on Your Tajikistan Validation

Ensure your process validation documentation is robust, appropriately translated, and immediately acceptable to the SSSHSPP, securing your necessary approvals and market access in Tajikistan.

To receive a Technical Scope and Commercial Proposal tailored for your Tajikistani project, simply provide:

• Product: Dosage form (e.g., solid oral, injectable, API) and Batch Size

• Target Status: New Registration / Renewal

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

• Existing Data: Any current validation documents or SSSHSPP deficiency letters.