🇺🇦 ValiPro: SEC, EU GMP & eCTD Process Validation Services for Ukraine

Achieve Compliance and Secure Product Registration in Ukraine by Aligning with EU/ICH Standards and eCTD Submission Requirements.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the Ukrainian market. Our documentation is built for full compliance with the rigorous standards enforced by the State Expert Center (SEC), which requires strict adherence to international guidelines.

Key compliance pillars include:

• Mandatory compliance with EU Good Manufacturing Practice (EU GMP) guidelines (adopted in Ukraine).

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

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

🌟 Why Ukraine/eCTD Validation is Crucial

Ukraine offers multiple routes to market, including standard registration and accelerated procedures based on recognition of Stringent Regulatory Authorities (SRAs). All require an impeccable quality dossier.

• eCTD Submission Mandate: As of August 2025, the eCTD format is mandatory for new registrations and is used for renewals and variations. We ensure your validation reports and summaries are precisely integrated into Module 3 (Quality), aligning with the ICH structure.

• EU GMP Recognition & Audit: Foreign manufacturers must provide a GMP Certificate or a Conclusion of Compliance. The SMDC may recognize certificates from a list of 35 countries (including EU Member States, US, UK, Canada, etc.) via an accelerated procedure. If the GMP certificate is not from a recognized country, a mandatory on-site inspection is conducted by the SMDC. Robust, EU-aligned validation data is essential for both recognition and inspection defense.

• Recognition Procedure: Ukraine offers an accelerated registration route through recognition of products registered in countries with high quality standards (EU, US, UK, etc.). Even this fast-track route requires the submission of the full eCTD Modules 1-5, meaning your validation data must meet the SRA-level standard.

• Quality Control Methods (QCM): The approved QCM must be provided, which necessitates thoroughly validated analytical methods (analytical method validation - AMV) to prove they are suitable for their intended purpose.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Ukrainian market:

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

• GMP/SMDC Readiness: Foreign facilities preparing for a potential SMDC GMP inspection or seeking recognition of their existing GMP certificate.

• eCTD Quality Module: Firms needing expert preparation of the full Module 3, including process validation (3.2.P.3.5), cleaning validation, and analytical method validation.

• Language Adaptation: Companies requiring accurate presentation of technical summaries in the Ukrainian language for Modules 1 and 3, as required by the SEC.

🛠️ Our Process Validation Services for Ukraine and EU Standards

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

ServiceUkraine / EU GMP / eCTD FocusPVP & PVR PreparationCustom protocols and reports aligned with EU GMP Annex 15, detailing the entire validation lifecycle and demonstrating control.eCTD Module 3 IntegrationStructuring validation summaries and data precisely for the eCTD Module 3 (section 3.2.P.3.5) and ensuring compliance with the required Ukrainian language summaries.Analytical Validation SupportPreparation of AMV reports for all quality control methods to support the required submission of the approved QCM.GMP/SMDC Audit DefenseReviewing and remediating validation documentation to address common findings during SMDC inspections, particularly those related to process control and technology transfer.

📜 Regulatory Standards We Follow

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

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

• eCTD Specification: The required structure and format for all registration dossiers.

• ICH Q8, Q9, Q10: The underlying scientific foundation for the quality requirements followed by the SEC.

🤝 Get Started on Your Ukraine Validation

Ensure your process validation documentation is robust, correctly formatted, and immediately acceptable to the State Expert Center, securing your necessary approvals and market access in Ukraine.

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

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

• Target Status: New Registration / Renewal / Recognition Procedure

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

• Existing Data: Any current validation documents or SEC/SMDC deficiency letters.