🇰🇬 ValiPro: EAEU GMP & eCTD Process Validation Services for Kyrgyzstan

Achieve Full EAEU Compliance via Kyrgyzstan with Validation Documentation Aligned to EAEU GMP and Unified Registration Requirements.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the market in Kyrgyzstan and the wider EAEU. Our documentation is built for full compliance with the rigorous standards enforced by the Kyrgyz competent authority.

Key compliance pillars include mandatory adherence to EAEU Good Manufacturing Practice (EAEU GMP) Rules and the submission of the registration dossier in the EAEU Common Technical Document (eCTD) format.

🌟 Why EAEU/Kyrgyzstan Validation is Critical

Kyrgyzstan's adoption of the EAEU framework means local national rules have been superseded by unified, high-standard regulations, demanding immediate compliance with the international GMP and dossier standards.

• EAEU GMP Mandate and Audit: Compliance with EAEU GMP Rules (based on WHO/EU GMP) is mandatory. Foreign manufacturing sites must hold a valid EAEU GMP Certificate issued by an EAEU member state inspectorate. The assessment of quality, including process validation, is a critical part of the required Inspection of the Manufacturing Site before product registration.

• eCTD Submission Format: The registration dossier must be submitted in the electronic EAEU CTD (eCTD) format. Your validation reports are a mandatory component of Module 3 (Quality) (specifically section 3.2.P.3.5, Process Validation). The dossier must also include a mandatory Normative Document (ND) outlining the quality control methods and specifications, which relies directly on validated procedures.

• 2025 Compliance Deadline: The deadline of December 31, 2025, for bringing all older national dossiers into compliance with the EAEU eCTD format is a major regulatory event. This accelerated procedure requires robust and complete validation documentation updates.

• Analytical Examination: The registration process includes an Analytical Expert Examination, where the State body tests product samples and checks the reproducibility of analytical procedures. This requires strong Analytical Validation documentation.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Kyrgyzstani market via the unified EAEU procedures:

• EAEU Exporters: Targeting registration via the EAEU Mutual Recognition Procedure (MRP) or Decentralized Procedure (DCP), using Kyrgyzstan as the Reference Member State (RMS) or a Concerned Member State (CMS).

• Dossier Transition: Companies needing to update their existing national registration dossiers into the required EAEU eCTD format before the December 31, 2025 deadline.

• EAEU GMP Audit Readiness: Foreign facilities preparing for an EAEU GMP inspection by a Kyrgyzstani or other EAEU inspectorate.

• CTD Module 3 Quality: Firms needing expert preparation of Module 3 to meet the high quality assessment standards.

🛠️ Our Process Validation Services for Kyrgyzstan and EAEU

We provide complete, scientifically sound, and document-intensive support to meet the expectations for EAEU-aligned quality data.

ServiceKyrgyzstan / EAEU GMP / eCTD FocusPVP & PVR PreparationCustom protocols and reports aligned with EAEU GMP Rules, specifically covering process and cleaning validation, demonstrating consistent quality and control.eCTD Module 3 IntegrationStructuring validation summaries and data precisely for the eCTD Module 3 (section 3.2.P.3.5) required by the EAEU, including the Russian-language summaries.Normative Document SupportProviding documentation that directly feeds the mandatory Normative Document (ND) and supports the quality control method description.2025 Transition Gap AnalysisComprehensive review of older national validation documents to identify gaps against the new EAEU CTD content requirements for the compliance deadline.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced in Kyrgyzstan:

• EAEU GMP Rules (Decision No. 78): The mandatory benchmark for manufacturing practice compliance.

• EAEU CTD / eCTD: The required structure and format for all registration dossiers.

• National Law No. 405 (Superseded): Ensuring any remaining national requirements are also met during the transition.

🤝 Get Started on Your Kyrgyzstan Validation

Ensure your process validation documentation is robust and immediately acceptable for EAEU registration, securing your necessary approvals and market access in Kyrgyzstan.

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

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

• Target Status: EAEU Unified Registration / Transition to EAEU CTD / GMP Inspection

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

• Existing Data: Any current validation documents or EAEU/local deficiency letters.