Analytical Method Validation Services – Mexico

Ensuring Accuracy. Compliance. Regulatory Confidence for Mexico Regulatory Submissions

VALIDEX, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Analytical Method Validation (AMV) services for Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Finished Products, fully compliant with Mexican regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Mexico with COFEPRIS-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of COFEPRIS queries for product registration (Registro Sanitario), manufacturing/import approvals, variations, and export dossiers.

Our Core Expertise – Mexico Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by COFEPRIS, under the Ministry of Health (Secretaría de Salud), United Mexican States.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by COFEPRIS Mexico
• Accuracy, precision, linearity, robustness, and specificity
• USP / BP / Ph. Eur. / IP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with COFEPRIS & WHO expectations
• Compliance with ICH Q3A / Q3B / Q3D (elemental impurities) and pharmacopoeial limits

✅ Dissolution Method Validation

• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with COFEPRIS product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C adopted by Mexico
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, and precision

Products Covered – Mexico

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, powders, sachets)
✅ Injectable formulations (sterile & non-sterile)
✅ Semi-solid & liquid dosage forms
✅ Modified-release and controlled-release products

Regulatory Compliance – Mexico

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• COFEPRIS Technical & Registration Requirements
• General Health Law of Mexico (Ley General de Salud)
• Mexican Official Standards (NOMs) for medicines
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by COFEPRIS
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Mexico

VALIDEX provides complete COFEPRIS query management, including:

✅ Responses to COFEPRIS deficiency letters and technical evaluation queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during COFEPRIS dossier reviews, inspections, and audits

Why Choose VALIDEX for Mexico?

✔ Strong understanding of COFEPRIS & Latin America regulatory expectations
✔ ICH-aligned, WHO-compliant documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines
✔ Strict confidentiality and data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Mexico

• Analytical Method Validation Protocols (COFEPRIS-compliant)
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / Non-CTD summary documents for COFEPRIS submissions
• Regulatory query response packages
• Method transfer, verification, and re-validation documentation

Industries We Serve in Mexico

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic and branded formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers, distributors, and MAHs
• Regulatory and dossier consulting firms

National & Export Support – Mexico

VALIDEX supports Analytical Method Validation for:

• Mexico domestic product registration (COFEPRIS)
• Manufacturing and import authorization applications
• Export dossiers prepared for Mexico, Latin America, and WHO-referenced markets

Partner with VALIDEX – Mexico

Achieve COFEPRIS-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Mexico.