🇧🇯 Analytical Method Validation Services – Benin

Ensuring Accuracy. Compliance. Regulatory Confidence for Benin 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 in full compliance with Benin's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Benin with Autorité Nationale de Réglementation Pharmaceutique (ANRP)-compliant analytical validation, ICH-aligned documentation, and post-submission handling of ANRP queries for drug registration, licensing, and import/export requirements.

🇧🇯 Our Core Expertise – Benin Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Autorité Nationale de Réglementation Pharmaceutique (ANRP) and internationally recognized standards (often following guidelines from WHO and pharmacopoeias).

• ✅ Assay Method Validation

  • Potency and content determination

  • Validation as per ICH Q2 (R1 / R2) aligned with ANRP expectations (often referencing WHO guidelines)

  • Accuracy, precision, linearity, robustness, and specificity

  • BP/USP/EP harmonized methods

• ✅ Impurities Method Validation

  • Related substances & degradation product profiling

  • Identification and quantification of impurities

  • Stability-indicating method validation as per ICH and WHO-GMP

• ✅ Dissolution Method Validation

  • Immediate & modified release products

  • Discriminatory dissolution method development

  • Media selection, sink condition assessment, and method robustness

  • Compliance with ANRP product registration requirements

• ✅ Residual Solvents Method Validation

  • Gas Chromatographic (GC) method validation

  • Compliance with ICH Q3C adopted globally, aligning with ANRP's quality expectations

  • Class I, II & III residual solvents

  • Limits, system suitability, accuracy, and precision

🇧🇯 Products Covered – Benin

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms (tablets, capsules, sachets)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

• ✅ Modified & controlled release products

🇧🇯 Regulatory Compliance – Benin

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)

• ANRP Guidelines and national pharmaceutical legislation

• WHO-GMP recommendations, widely accepted in West Africa

• United States Pharmacopeia (USP)

• European Pharmacopoeia (EP)

• British Pharmacopoeia (BP)

🇧🇯 Post-Submission Regulatory Support (Benin)

VALIDEX provides complete ANRP query management, including:

• ✅ Response to ANRP deficiency letters

• ✅ Scientific justification for validation parameters

• ✅ Data gap assessment & corrective documentation

• ✅ Revised validation protocols and reports

• ✅ Technical support during regulatory inspections & audits

🇧🇯 Why Choose VALIDEX for Benin?

• ✔ Strong understanding of Benin's ANRP regulatory expectations and regional standards

• ✔ ICH-aligned documentation focused on West African compliance norms

• ✔ Inspection-ready and audit-compliant validation reports

• ✔ Fast turnaround timelines

• ✔ Strict confidentiality & data integrity

• ✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

🇧🇯 Our Deliverables – Benin

• Analytical Method Validation Protocols (ANRP-compliant)

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD / Non-CTD summary documents for ANRP submissions

• Regulatory query response packages

• Method transfer & verification documentation

🇧🇯 Industries We Serve in Benin

• Pharmaceutical manufacturing companies

• API traders and importers

• Generic formulation companies

• Contract Manufacturing Organizations (CMOs)

• Import and Distribution companies

• Regulatory & dossier consulting firms

🇧🇯 National & Export Support

VALIDEX supports Analytical Method Validation for:

• Benin domestic approvals (ANRP registration)

• Manufacturing licenses & product permissions

• Export dossiers for regional and international shipment from Benin

🇧🇯 Partner with VALIDEX – Benin

Achieve ANRP-ready analytical validation with confidence.

From method validation to regulatory approvals, VALIDEX is your trusted Benin scientific and regulatory partner.