🇧🇬 ValiPro: BDA, EU GMP & eCTD Process Validation Services for Bulgaria

Ensure Seamless Access to the Bulgarian 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 Bulgaria. Our documentation is built for full compliance with the rigorous standards enforced by the Bulgarian Drug Agency (BDA), 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 BDA/EU Validation is Crucial for Bulgaria

Market Authorization (MA) in Bulgaria 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 BDA enforces EU GMP guidelines rigorously. Manufacturers must hold a valid GMP certificate, and the BDA is a participating member of the EU/EEA inspection network. Validation documentation must align with EudraLex Volume 4, Annex 15 (Qualification and Validation), covering the entire process lifecycle (Design, Qualification, and Continuous Verification).

• eCTD Submission: Registration is typically handled via the Decentralized (DCP) or Mutual Recognition Procedure (MRP). 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 BDA'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" and the foundational ICH Q8, Q9, and Q10 guidelines.

• National Procedure: While the DCP/MRP is common, Bulgaria also has a National Procedure. This still requires the dossier to be filed in eCTD format with all documentation compliant with EU requirements.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Bulgarian 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 BDA or another EU inspectorate.

• CTD Module 3 Quality: Firms needing expert preparation of Module 3 to meet BDA's technical standards, including both traditional and modern Continuous Process Verification (CPV) validation approaches.

🛠️ Our Process Validation Services for Bulgaria and the EU

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

ServiceBDA / EU GMP / EMA FocusPVP & PVR PreparationProtocols and reports aligned with EudraLex Vol. 4, Annex 15, detailing the entire validation lifecycle 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 Quality by Design (QbD) principles and the overall Pharmaceutical Quality System (PQS).Deficiency Response SupportExpert technical support to address and close quality (Module 3) non-conformities issued by the BDA during the DCP/MRP assessment process.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the Bulgarian Drug Agency:

• 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 BDA/EU Validation

Ensure your process validation documentation is robust and immediately acceptable to the Bulgarian Drug Agency, securing your necessary approvals and market access in Bulgaria and the European Union.

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

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

• Target Procedure: DCP (Bulgaria 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 BDA/EU deficiency letters.