🇦🇲 ValiPro: EAEU GMP & eCTD Process Validation Services for Armenia

Navigate the Unified EAEU Market via Armenia with Validation Documentation Aligned to EAEU GMP and SCDMTE Requirements.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the market in Armenia. Our documentation is built for full compliance with the rigorous standards enforced by the Scientific Center of Drug and Medical Technology Expertise (SCDMTE).

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

🌟 Why EAEU/Armenian Validation is Crucial

Armenia is fully integrated into the EAEU framework, meaning that for pharmaceutical trade, compliance with unified, international standards is mandatory.

• EAEU GMP Mandate and Inspection: Compliance with EAEU GMP Rules (which are aligned with WHO/EU GMP) is required. Foreign manufacturing sites must hold an EAEU GMP Certificate issued by an EAEU member state inspectorate. Armenia recognizes GMP certificates from various international authorities (EU/EEA, PIC/S members, US FDA), simplifying the process, but the underlying validation data must still meet EAEU standards.

• eCTD Submission Format: All new registrations and the transition of old national licenses must be submitted in the electronic EAEU CTD (eCTD) format. Your validation reports are a key part of Module 3 (Quality), specifically section 3.2.P.3.5.

• 2025 Compliance Deadline: All products registered under the older national legislation must be brought into compliance with the EAEU requirements by December 31, 2025. This transition requires a complete update of the dossier, including validation data, to the eCTD format.

• Simplified Registration: Armenia offers a simplified registration procedure (30 days) for medicinal products already registered in the EU, USA, or Japan. Even for this fast-track route, the quality data in the CTD must be complete and robust, aligning with the standards of the recognized SRA.

• Laboratory Testing: For the general registration procedure, samples of the finished product and reference standards are required for laboratory expert evaluation by the SCDMTE. Robust Analytical Validation documentation is essential to ensure the reproducibility of your control methods.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Armenian market via the EAEU procedures:

• EAEU Exporters: Targeting registration via the EAEU Mutual Recognition Procedure (MRP) or Decentralized Procedure (DCP).

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

• Simplified Registration: Firms leveraging the 30-day simplified route, needing fast, high-quality CTD Module 3 compilation.

• CTD Module 3 Quality: Firms needing expert preparation of the Quality Module to meet SCDMTE's rigorous assessment standards.

🛠️ Our Process Validation Services for Armenia and EAEU

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

ServiceArmenia / EAEU GMP / eCTD FocusPVP & PVR PreparationCustom protocols and reports aligned with EAEU GMP Rules, specifically covering process and cleaning validation.eCTD Module 3 IntegrationStructuring validation summaries and data precisely for the eCTD Module 3 (section 3.2.P.3.5) and ensuring accurate Russian (or Armenian) translation of key summaries.Analytical Validation SupportPreparation of validation/verification reports for all control methods, ensuring compliance with the analytical examination and testing requirements.2025 Transition SupportComprehensive gap analysis and remediation of older validation documentation to meet the EAEU CTD content requirements for the mandatory compliance deadline.

📜 Regulatory Standards We Follow

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

• 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.

• Armenian Law “On Medicinal Products” (2016): The national law governing medicinal product circulation.

🤝 Get Started on Your Armenian Validation

Ensure your process validation documentation is robust and immediately acceptable to the SCDMTE and the EAEU inspectorate, securing your necessary approvals and market access in Armenia and the wider EAEU.

To receive a Technical Scope and Commercial Proposal tailored for your Armenian/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 / Simplified Registration

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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