🇷🇴 ValiPro: NAMMDR, EU GMP & eCTD Process Validation Services for Romania

Ensure Seamless Access to the Romanian and European Market with Validation Documentation Aligned to EU/EMA Guidelines.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting Romania. Our documentation is built for full compliance with the rigorous standards enforced by the NAMMDR, which implements the pharmaceutical legislation of the European Union.

Key compliance pillars include:

• Mandatory adherence to EU Good Manufacturing Practice (EU GMP) Guidelines (EudraLex Volume 4).

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

• Alignment with the EMA's scientific guidelines on quality and validation.

🌟 Why NAMMDR/EU Validation is Crucial for Romania

Market Authorization (MA) in Romania is achieved through standard EU-level procedures, meaning your validation documents must satisfy the highest European standards for review and acceptance.

• EU GMP Mandate & Inspection: The NAMMDR enforces EU GMP guidelines rigorously and is an active participant in the EU/EEA inspection network. Validation documentation must align with EudraLex Volume 4, Annex 15 (Qualification and Validation). This regulation explicitly requires manufacturers to validate manufacturing processes, especially where the output cannot be fully verified by subsequent testing.

• eCTD Submission: Registration is handled via the Decentralized (DCP) or Mutual Recognition Procedure (MRP), or the National Procedure. All require the dossier to be submitted in the electronic eCTD format. Process Validation reports and the Quality Overall Summary (QOS) are mandatory within Module 3 (Quality), section 3.2.P.3.5.

• EMA Scientific Guidelines: The NAMMDR's assessors utilize the scientific guidelines published by the EMA to assess quality data. This requires your process validation to follow the modern, lifecycle approach described in the EMA's "Guideline on process validation for finished products," incorporating principles from ICH Q8, Q9, and Q10.

• Local Compliance: The NAMMDR maintains surveillance of quality and manufacturing units, including publishing non-compliance reports for both GMP and GDP (Good Distribution Practice). An audit-ready validation package is key to successful compliance.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Romanian market via the European procedures:

• EU Exporters: Targeting human and veterinary drug registration through the Centralized, DCP, or MRP routes.

• EU GMP Audit Readiness: Foreign facilities preparing for an EU GMP inspection by the NAMMDR or another EU inspectorate.

• CTD Module 3 Quality: Firms needing expert preparation of Module 3 to meet NAMMDR's technical standards, supporting all validation approaches (Traditional, Continuous Process Verification, or Hybrid).

🛠️ Our Process Validation Services for Romania and the EU

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

ServiceNAMMDR / EU GMP / EMA FocusPVP & PVR PreparationProtocols and reports aligned with EudraLex Vol. 4, Annex 15, detailing the entire validation lifecycle (IQ, OQ, PQ) and demonstrating compliance with EU regulatory expectations.eCTD Module 3 IntegrationStructuring validation summaries and data precisely for the eCTD Module 3 (section 3.2.P.3.5), suitable for submission via the Common European Submission Portal (CESP).ICH Q8/Q10 IntegrationDocumentation that explicitly links process validation to the Pharmaceutical Quality System (PQS) and Quality Risk Management principles.Deficiency Response SupportExpert technical support to address and close quality (Module 3) non-conformities issued by the NAMMDR during the assessment process.

📜 Regulatory Standards We Follow

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

• EudraLex Volume 4 (EU GMP): The mandatory guideline for manufacturing practice.

• EMA Scientific Guidelines: Specifically those on Process Validation and Quality.

• ICH Q8, Q9, Q10: The globally harmonized principles of the Quality by Design lifecycle approach.

🤝 Get Started on Your NAMMDR/EU Validation

Ensure your process validation documentation is robust and immediately acceptable to the NAMMDR, securing your necessary approvals and market access in Romania and the European Union.

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

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

• Target Procedure: DCP (Romania RMS?) / MRP / National Registration

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

• Existing Data: Any current validation documents or NAMMDR/EU deficiency letters.