🇲🇽 ValiPro: COFEPRIS, Reliance & NOM-059-SSA1-2015 Validation Services for Mexico
Achieve Rapid and Compliant Market Authorization in Mexico by Aligning Validation Documentation with COFEPRIS's High-Vigilance Standards and leveraging the Reliance Mechanism.
ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the Mexican market. Our documentation is built for full compliance with the strict standards enforced by COFEPRIS and its specific Mexican Official Norms (NOMs).
Key compliance pillars include:
Mexican Official Norm (NOM-059-SSA1-2015): Mandatory adherence to COFEPRIS's specific Good Manufacturing Practice (GMP) requirements.
Reliance Pathway: Accelerated review for products registered by Reference Regulatory Authorities (RRAs) (e.g., USFDA, EMA, Health Canada, TGA).
CTD Submission: Dossiers are required to be submitted in the Common Technical Document (CTD) format, with validation data in Module 3 (Quality).
Bioequivalence: Mandatory Bioequivalence (BE) studies for generic drugs.
🌟 Why COFEPRIS Validation is Crucial
COFEPRIS's high standard of review means the underlying scientific data (validation) must be robust, complete, and perfectly structured to support claims of quality, safety, and efficacy, especially when utilizing the fast-track routes.
Reliance Mechanism (Abbreviated Regulatory Route): Products approved and marketed by RRAs are eligible for an abbreviated review. This process relies on the integrity of the original registration dossier. Your validation documentation must meet the ICH Q8/Q9/Q10 principles underlying the RRA's approval to be acceptable to COFEPRIS. COFEPRIS may waive the local GMP inspection if the facility holds a certificate from a recognized RRA.
NOM-059-SSA1-2015: This is the Mexican official standard for GMP. While aligned with international guidelines (ICH/PIC/S), it has specific local requirements. Your validation documentation must demonstrate compliance with the spirit and letter of this NOM, particularly regarding the control of critical processes and equipment.
CTD Module 3: The dossier must be presented in the CTD format. The "Quality Information" (Module 3) is where Process Validation (3.2.P.3.5), Analytical Method Validation (3.2.P.5), and Cleaning Validation data are summarized and reported. Accuracy and organization in this module are essential for a smooth COFEPRIS review.
Bioequivalence for Generics: Generic drug applications must include a BE study against a locally approved reference product. The BE study must be conducted on a batch manufactured under validated, controlled conditions. Your validation reports are integral to the BE documentation.
Language Requirement: All official documents in the dossier must be in Spanish, often requiring translation by a certified translator (Perito Traductor). Technical summaries and validation reports must be prepared for accurate and compliant translation.
🎯 Compliance Focus: Who We Support
We work with international manufacturers targeting the Mexican market:
RRA Exporters: Leveraging the Abbreviated Regulatory Route by ensuring their existing validation dossiers align with ICH and support the RRA approval.
Generic Exporters: Requiring validation documentation explicitly linked to the Biobatch and prepared to support the mandatory BE studies.
NOM-059-SSA1-2015 Compliance: Companies needing to ensure their Process and Cleaning Validation protocols meet Mexico's specific GMP regulations.
CTD Module 3 Quality: Firms needing expert preparation and summarization of the Quality Module to meet COFEPRIS's technical standards.
🛠️ Our Process Validation Services for Mexico
We provide complete, scientifically sound, and document-intensive support tailored to COFEPRIS's technical requirements.
ServiceMexico / COFEPRIS / NOM-059-SSA1-2015 FocusPVP & PVR PreparationProtocols and reports aligned with ICH/PIC/S principles and structured to demonstrate compliance with the requirements of NOM-059-SSA1-2015.CTD Module 3 IntegrationStructuring validation summaries and data precisely for the CTD Module 3 (section 3.2.P.3.5) for fast review.Analytical Method Validation (AMV)Preparation of detailed AMV reports (compliant with ICH Q2(R1)) to support finished product specifications and BE studies.Spanish Translation ReadinessPreparing concise, accurate technical summaries suitable for official Perito Traductor translation to avoid technical inaccuracies in the final submission.
📜 Regulatory Standards We Follow
Our documentation is engineered to align with the core standards adopted and enforced by COFEPRIS:
General Health Law (Ley General de Salud, LGS): The overarching legal framework.
NOM-059-SSA1-2015: Official Mexican Norm for Good Manufacturing Practices for Medicines.
CTD Format: The required structure for the sanitary registration dossier.
🤝 Get Started on Your Mexico Validation
Ensure your process validation documentation is robust, meets the high standards of a PAHO/WHO Reference Authority, and is formatted correctly for COFEPRIS review, securing your approvals and market access in Mexico.
To receive a Technical Scope and Commercial Proposal tailored for your Mexican project, simply provide:
Product: Dosage form (e.g., solid oral, injectable, biologic) and Batch Size
Target Status: Reliance/Abbreviated Route / Standard New Molecule Registration
Manufacturing Process: Overview of critical steps and control strategy
Timeline: Submission date
Existing Data: Any current validation documents or COFEPRIS deficiency letters.