Analytical Method Validation Services – Madagascar

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

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Madagascar with AGMED-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of regulatory queries for product registration, marketing authorization, manufacturing/import approvals, and export dossiers.

Our Core Expertise – Madagascar Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Agence du Médicament de Madagascar (AGMED) under the Ministry of Public Health, Republic of Madagascar.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by AGMED Madagascar
• Accuracy, precision, linearity, robustness, and specificity
• USP / BP / EP / IP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with AGMED & WHO expectations
• Compliance with ICH Q3A / Q3B and pharmacopoeial impurity 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 AGMED product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Madagascar

✅ 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 – Madagascar

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• AGMED Registration Guidelines & Technical Requirements
• Madagascar Public Health Code & Pharmaceutical Regulations
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by AGMED)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Madagascar

VALIDEX provides complete AGMED query management, including:

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

Why Choose VALIDEX for Madagascar?

✔ Strong understanding of AGMED regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Madagascar
✔ 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 – Madagascar

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

Industries We Serve in Madagascar

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

National & Export Support – Madagascar

VALIDEX supports Analytical Method Validation for:

• Madagascar domestic product registration (AGMED)
• Manufacturing and import authorization applications
• Export dossiers prepared for AGMED-regulated and WHO-referenced markets

Partner with VALIDEX – Madagascar

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