Analytical Method Validation Services – Burkina Faso

Ensuring Accuracy. Compliance. Regulatory Confidence for Burkina Faso 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 Burkina Faso regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Burkina Faso with DGPML-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 – Burkina Faso Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Direction Générale de la Pharmacie, du Médicament et des Laboratoires (DGPML) under the Ministry of Health, Burkina Faso.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Burkina Faso

✅ 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 – Burkina Faso

All Analytical Method Validation activities are conducted in accordance with:

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

Post-Submission Regulatory Support – Burkina Faso

VALIDEX provides complete DGPML query management, including:

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

Why Choose VALIDEX for Burkina Faso?

✔ Strong understanding of DGPML regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Burkina Faso
✔ 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 – Burkina Faso

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

Industries We Serve in Burkina Faso

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

National & Export Support – Burkina Faso

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Burkina Faso

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