🇧🇮 Analytical Method Validation Services – Burundi

Ensuring Accuracy. Compliance. Regulatory Confidence for Burundi 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 Burundi's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Burundi with compliance aligned with the Agence Nationale de Réglementation et de Contrôle Pharmaceutique (ANRCP), ICH-aligned documentation, and post-submission handling of regulatory queries for drug registration, licensing, and import/export requirements.

🇧🇮 Our Core Expertise – Burundi Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the ANRCP and internationally accepted pharmacopoeial standards, often referencing WHO and regional East African Community (EAC) guidelines.

• ✅ Assay Method Validation

  • Potency and content determination

  • Validation as per ICH Q2 (R1 / R2) aligned with regional and ANRCP quality expectations

  • 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 product registration requirements, following international norms

• ✅ Residual Solvents Method Validation

  • Gas Chromatographic (GC) method validation

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

  • Class I, II & III residual solvents

  • Limits, system suitability, accuracy, and precision

🇧🇮 Products Covered – Burundi

• ✅ 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 – Burundi

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)

• ANRCP Guidelines and national pharmaceutical regulations

• WHO-GMP recommendations, widely accepted in the region

• United States Pharmacopeia (USP)

• European Pharmacopoeia (EP)

• British Pharmacopoeia (BP)

🇧🇮 Post-Submission Regulatory Support (Burundi)

VALIDEX provides complete regulatory query management, assisting with responses to ANRCP and other competent authorities, including:

• ✅ Response to regulatory 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 Burundi?

• ✔ Strong understanding of Burundi's ANRCP regulatory expectations and regional standards (EAC)

• ✔ ICH-aligned documentation focused on African and international 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 – Burundi

• Analytical Method Validation Protocols (Regionally compliant)

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD / Non-CTD summary documents for submissions

• Regulatory query response packages

• Method transfer & verification documentation

🇧🇮 Industries We Serve in Burundi

• 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:

• Burundi domestic approvals (Product registration)

• Manufacturing licenses & product permissions

• Export dossiers for regional and international shipment from Burundi

🇧🇮 Partner with VALIDEX – Burundi

Achieve regulatory-ready analytical validation with confidence.

From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner in Burundi and the East African region.