Analytical Method Validation Services – Uruguay

Ensuring Accuracy. Compliance. Regulatory Confidence for Uruguay 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 Uruguay regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Uruguay with MSP-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Ministry of Public Health (MSP) queries for product registration (Registro de Medicamentos), manufacturing/import approvals, and export dossiers.

Our Core Expertise – Uruguay Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Ministry of Public Health (MSP), Oriental Republic of Uruguay, aligned with MERCOSUR and WHO expectations.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by MSP Uruguay
• 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 MSP & 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 Uruguay product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Uruguay

✅ 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 – Uruguay

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Ministry of Public Health (MSP) registration & technical requirements
• Uruguayan Medicines & Health Regulations
• MERCOSUR technical guidelines (where applicable)
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by MSP
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Uruguay

VALIDEX provides complete MSP query management, including:

✅ Responses to MSP 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 MSP dossier reviews, inspections, and audits

Why Choose VALIDEX for Uruguay?

✔ Strong understanding of Uruguay & MERCOSUR 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 – Uruguay

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

Industries We Serve in Uruguay

• 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 – Uruguay

VALIDEX supports Analytical Method Validation for:

• Uruguay domestic product registration (MSP)
• Manufacturing and import authorization applications
• Export dossiers prepared for Uruguay, MERCOSUR countries, and WHO-referenced markets

Partner with VALIDEX – Uruguay

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