🇺🇾 ValiPro: MSP, CCCM & Therapeutic Equivalence Validation Services for Uruguay

Navigate Uruguay's Registration Process by Aligning Validation Data with MSP's Dossier Requirements, Facilitating Quality Control by the CCCM, and Supporting Bioequivalence.

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

Key compliance pillars include:

• Good Manufacturing Practice (GMP): Mandatory submission of a GMP Certificate and adherence to GMP standards.

• Therapeutic Equivalence: Strict requirements for Bioavailability and Equivalence Studies for specific medicines (Decree 12/2007).

• Official Quality Control: The dossier must support testing by the official laboratory, the Commission for the Control of Drug Quality (Comisión para el Control de Calidad de Medicamentos, CCCM).

• Dossier Documentation: Submission of a detailed quality dossier, increasingly accepted or expected in the Common Technical Document (CTD) format.

🌟 Why MSP/CCCM Validation is Crucial

Uruguay's system demands high-quality manufacturing and control data, as the official laboratory (CCCM) performs quality control checks on marketed products, and the MSP enforces bioequivalence.

• Manufacturing Process Detail: The registration dossier requires extensive detail on the manufacturing process, including the Batch Formula, Description of the Manufacturing Process and Process Controls, and Batch Records. Your Process Validation Report provides the scientific evidence that the process is consistent and reproducible, which underpins the integrity of the submitted batch records.

• Official Quality Control (CCCM): The CCCM is the official drug quality control laboratory (prequalified by PAHO/WHO) and plays a key role in monitoring marketed drugs.

  • Reference Standards: Upon starting marketing, the company must provide the CCCM with Reference Standards necessary for the quality control of the Drug Product.

  • Analytical Method Validation (AMV): The dossier must include Specifications and Analytical Procedures for the Drug Product, along with the Validation of Analytical Procedures. Robust AMV is critical to ensure the CCCM can reliably perform post-market quality testing.

• Bioequivalence (Interchangeability): The legal framework (Decree 12/2007 and subsequent decrees) mandates that certain medicines demonstrate Interchangeability through Bioavailability/Bioequivalence (BA/BE) studies performed in authorized centers. The manufacturing batch used for the BE study must be produced under validated control.

• Dossier Format: Uruguay accepts and encourages international harmonization, with the CTD format being referenced, particularly for biological and biotechnological products. Your validation summaries and reports should be structured to align with CTD Module 3 (Quality) standards.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Uruguayan market:

• Generic Exporters: Requiring validation documentation that supports the Biobatch used for BA/BE studies and includes the mandatory Analytical Method Validation data.

• CCCM Readiness: Firms needing to ensure their Analytical Method Validation (AMV) reports and finished product specifications are robust and reliable enough for the CCCM's official testing and verification.

• Quality Dossier Integration: Companies needing to compile their manufacturing and control data into the required MSP dossier structure.

🛠️ Our Process Validation Services for Uruguay

We provide complete, scientifically sound, and document-intensive support tailored to the content requirements of the MSP submission.

ServiceUruguay / MSP / CCCM FocusPVP & PVR PreparationProtocols and reports aligned with ICH/WHO GMP principles, documenting manufacturing and cleaning processes, including three consecutive batches.Analytical Method Validation (AMV)Preparation of detailed AMV reports for the Drug Product to satisfy the mandatory dossier requirement and facilitate CCCM testing upon market entry.BA/BE LinkageEnsuring the manufacturing process documentation provides clear traceability to the Biobatch used for the required Therapeutic Equivalence studies.Spanish Translation SupportAssistance in the accurate translation of technical validation summaries and key quality documents into Spanish for submission.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the MSP:

• Law 15443/1983 and Decrees 521/1984, 324/1999: The primary legal framework.

• Decrees 12/2007, 261/2009: The specific regulations governing Therapeutic Equivalence and Bioavailability.

• WHO/ICH GMP Principles: The underlying scientific benchmark recognized by the CCCM and MSP.

🤝 Get Started on Your Uruguay Validation

Ensure your process validation documentation is robust, meets the explicit requirements for analytical method validation, and is prepared to facilitate the CCCM's quality control, securing your necessary approvals and market access in Uruguay.

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

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

• Target Status: New Registration / Renewal (requiring updated GMP compliance)

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

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