🇲🇩 ValiPro: AMDM, EU-Harmonized GMP & CTD Process Validation Services for Moldova

The regulatory authority for pharmaceuticals in Moldova is the Medicines and Medical Devices Agency (Agenția Medicamentului și Dispozitivelor Medicale, AMDM).

Moldova is not a member of the European Union (EU) or the Eurasian Economic Union (EAEU), but its regulatory framework is undergoing active harmonization with EU/EMA standards as part of its path toward European integration.

🇲🇩 ValiPro: AMDM, EU-Harmonized GMP & CTD Process Validation Services for Moldova

Achieve Compliance and Secure Product Registration in Moldova by Aligning with AMDM's EU-Harmonized Quality and GMP Standards.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the Moldovan market. Our documentation is built for full compliance with the rigorous standards enforced by the AMDM.

Key compliance pillars include:

• Mandatory compliance with EU Good Manufacturing Practice (EU GMP) Guidelines (as adopted by AMDM).

• Mandatory submission of the registration dossier in the Common Technical Document (CTD) format.

• The availability of a Simplified Registration Procedure for products registered in major SRA countries.

🌟 Why AMDM/CTD Validation is Crucial

Moldova's commitment to EU harmonization means its technical requirements are high, even though it operates a national registration system.

• EU GMP Mandate & Inspection: The AMDM enforces adherence to Good Manufacturing Practices (GMP), drawing parallels with EU standards. Foreign manufacturers must submit a GMP Certificate from the manufacturing site. The AMDM reserves the right to conduct inspections, and robust, EU-aligned validation data is necessary to support the credibility of the submitted GMP certificate.

• CTD Submission Format: The registration dossier must be submitted in the CTD format, which is a core part of the harmonization efforts. We ensure your Process Validation reports and summaries are correctly integrated into Module 3 (Quality), section 3.2.P.3.5.

• Simplified Registration Procedure: Moldova offers a simplified registration route for medicinal products already authorized in the European Economic Area (EEA), Switzerland, USA, Canada, Japan, or Australia. Even in this route, the dossier (Modules 2-5) must be submitted electronically, and the quality data, including validation, must meet the SRA-level standard of the recognized country.

• Language Requirement: Documentation, including the Summary of Product Characteristics (SmPC) and patient information, must be submitted in the Romanian language. Technical summaries in the dossier can often be submitted in Romanian, English, or Russian.

• Laboratory Quality Control: The registration process includes a mandatory step of quality control of the finished product samples and reference substances by the national laboratory, requiring reliable Analytical Validation documentation.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Moldovan market:

• Pharmaceutical Exporters: Targeting registration via the Standard or Simplified procedure.

• GMP Readiness: Foreign facilities needing validation documentation that is fully aligned with EU GMP Annex 15 to support the required GMP compliance and potential AMDM audits.

• CTD Module 3 Quality: Firms needing expert preparation of the Quality Module to meet AMDM's exacting standards.

• Documentation Translation/Adaptation: Companies requiring accurate presentation of technical summaries in the necessary language (Romanian, Russian, or English) for the dossier.

🛠️ Our Process Validation Services for Moldova

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

ServiceAMDM / EU-Harmonized FocusPVP & PVR PreparationCustom protocols and reports aligned with EU GMP Annex 15 principles, detailing the entire validation lifecycle (IQ, OQ, PQ).CTD Module 3 IntegrationStructuring validation summaries and data precisely for the CTD Module 3 (section 3.2.P.3.5), suitable for AMDM assessment.Analytical Validation SupportPreparation of AMV reports for all analytical methods to support the mandatory laboratory verification of quality parameters.Deficiency Response SupportExpert technical support to address and close quality (Module 3) non-conformities issued by the AMDM during the specialized expert evaluation.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the Medicines and Medical Devices Agency:

• EU GMP Guidelines: The primary benchmark for manufacturing practice compliance (adopted via national legislation).

• CTD (Common Technical Document): The mandatory structure for all registration dossiers.

• ICH Quality Principles: The scientific foundation for validation requirements.

🤝 Get Started on Your Moldova Validation

Ensure your process validation documentation is robust, correctly formatted, and immediately acceptable to the AMDM, securing your necessary approvals and market access in Moldova.

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

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

• Target Status: Standard Registration / Simplified Registration

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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