Analytical Method Validation Services – Argentina

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

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

Our Core Expertise – Argentina Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT).

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Argentina

✅ 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 – Argentina

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• ANMAT Technical and Registration Requirements
• Argentine Medicines Law (Ley de Medicamentos)
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by ANMAT
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Argentina

VALIDEX provides complete ANMAT query management, including:

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

Why Choose VALIDEX for Argentina?

✔ Strong understanding of ANMAT & 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 – Argentina

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

Industries We Serve in Argentina

• 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 – Argentina

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Argentina

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