🇬🇪 ValiPro: RAMA, WHO/EU GMP & National Dossier Validation Services

Achieve Compliance and Secure Product Registration in Georgia by Aligning with RAMA's Stringent Quality and GMP Requirements.

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the Georgian market. Our documentation is built for full compliance with the rigorous standards enforced by the State Regulation Agency of Medical Activities (RAMA). RAMA strongly enforces international Good Manufacturing Practices (GMP), particularly those aligned with EU GMP and PIC/S standards, which must be proven for both registration procedures.

We specialize in supporting manufacturers to ensure their quality and manufacturing data—including process, cleaning, and analytical validation—is robust, technically sound, and prepared for the national dossier format, securing timely RAMA approvals.

🌟 Why RAMA-Ready Validation is Crucial

Georgia has a simplified procedure for products registered by high-standard regulatory authorities (SRAs), yet both pathways demand comprehensive quality and manufacturing data.

• Mandatory GMP Certification: Foreign manufacturing sites must provide GMP Certificates (or equivalent documentation) issued by the competent authorities of the countries-manufacturers. The Georgian regulatory framework is increasingly aligned with EU GMP and PIC/S standards, making validation documentation aligned with these principles essential proof of compliance.

• National Dossier Requirements: For the National Registration Procedure, the scientific and technical documentation (including chemical, pharmaceutical, and biological data) must be submitted. While the CTD format is generally not accepted for the national procedure, the required content—including detailed manufacturing process description, specifications, and stability data—is derived from the same ICH quality principles as CTD Module 3.

• Two Routes to Market:

  • Simplified Recognition: Applied to products registered in countries with high regulatory requirements. Requires submission of documentation including GMP Certificates and the Certificate of Pharmaceutical Product (CPP).

  • National Registration: Applicable to all other products. Requires submission of an extensive set of scientific and technical documents, including explicit manufacturing and quality data.

• Laboratory Testing: Sufficient samples and reference standards are required for quality control testing by RAMA (or a designated laboratory), emphasizing the need for robust Analytical Validation documentation.

🎯 RAMA Compliance Focus: Who We Support

We work closely with manufacturers and their local representatives in Georgia who need:

• Pharmaceutical Exporters: Targeting human and veterinary drug registration with the RAMA via either the Recognition or National procedure.

• GMP Conformance: Overseas facilities seeking RAMA acceptance of their GMP status, requiring evidence of robust Process Control and validation practices.

• National Dossier Quality: Preparation of the quality sections ensuring that all manufacturing and control data meets RAMA's technical expectations for the national format.

• Regulatory Responses: Firms addressing technical deficiencies or quality queries issued by RAMA assessors regarding manufacturing process controls and capability.

🛠️ Our RAMA Process Validation Services

We provide complete, scientifically sound, and document-intensive support tailored to the content requirements of the Georgian National Dossier.

ServiceRAMA / GMP / Quality FocusPVP & PVR PreparationCustom protocols and reports aligned with WHO/EU GMP principles, detailing the process validation lifecycle (Design, Qualification, Continuous Verification).National Dossier IntegrationStructuring validation summaries and data precisely to address the requirements for Scientific-technical documentation (chemical, pharmaceutical, and biological data), ensuring the data is easily found and assessed by RAMA experts.Analytical Validation SupportPreparation of validation protocols and reports for all analytical methods used to control the drug substance and drug product, essential for RAMA's laboratory testing.GMP Certificate SupportReviewing and supplementing existing validation documentation to ensure it fully supports the foreign manufacturer's GMP Certificate required for both registration pathways.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the State Regulation Agency of Medical Activities:

• EU GMP/PIC/S Guidelines: The operational benchmark for manufacturing practice compliance and validation scope.

• Law of Georgia on Drugs and Pharmaceutical Activity: The primary national legislation governing registration and pharmaceutical activities.

• ICH Quality Principles (Q8, Q9, Q10): While CTD is not mandatory, the underlying scientific and risk-based quality principles are implicitly followed by assessors.

🤝 Get Started on Your RAMA Validation

Ensure your process validation documentation is robust and immediately acceptable to the RAMA, securing your necessary approvals and market access in Georgia.

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

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

• Target RAMA Status: National Registration / Recognition Procedure

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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