Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Burkina Faso
ANRP-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory standards of Burkina Faso’s Agence Nationale de Régulation Pharmaceutique (ANRP).
All studies strictly follow ICH, WHO TRS, GCP, GLP, and ANRP requirements, ensuring pharmaceutical compliance for national product registration and international submissions.
💊 Core Services for Burkina Faso (ANRP) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by ANRP.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic indication.
• Ethics Approval: Approval from a recognized Comité d’Éthique or Institutional Review Board (IRB) in Burkina Faso.
• Protocol Development: ANRP-aligned BA/BE protocols designed according to ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic registration, dossier variations, and quality evaluations under ANRP.
• Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Assessment: f2 similarity factor for comparing dissolution profiles.
• Evaluation Methods: Both model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared in accordance with WHO TRS, ICH Q6A, and ANRP-recognized scientific criteria.
• IVIVC Modeling: Level A, B, and C correlation models for predicting in vivo drug behavior.
• Predictive PK Modeling: Supports regulatory justification for BE or biowaivers.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems for accurate drug quantification.
• Validation: Conducted per ICH M10, WHO standards, and ANRP-acceptable validation principles.
• Stability Methods: Stability-indicating method development for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Analysis Type: Non-compartmental analysis (NCA).
• BE Statistics: Statistical comparison following WHO, ICH, and internationally harmonized BE methodologies recognized by ANRP.
• Power & Sample Size: Determined using globally accepted methodologies for conclusive BE outcomes.
📑 ANRP-Ready Regulatory Documentation
We prepare complete regulatory submission documentation for Burkina Faso’s Agence Nationale de Régulation Pharmaceutique (ANRP), including:
• Clinical Study Protocol (ANRP-aligned)
• Informed Consent Forms (ICF) following local ethical regulations
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for Burkina Faso regulatory submission
✨ Why Choose BioEquiGlobal for the Burkina Faso Market?
DPML Burkina Faso–Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides comprehensive Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for Burkina Faso’s pharmaceutical regulatory framework.
Our DMF services are designed to meet the requirements of the Direction de la Pharmacie, du Médicament et des Laboratoires (DPML), Ministry of Health, Burkina Faso and comply with:
Burkina Faso Public Health Code
DPML Drug Registration Guidelines
WAEMU/UEMOA Pharmaceutical Regulations
GMP Guidelines accepted in Burkina Faso (WHO GMP aligned)
ICH Guidelines
CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import authorization & marketing authorization dossiers
• Export-oriented regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s Part)
Closed Part (Restricted / Confidential Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing in Burkina Faso.
Our Core DMF Services – Burkina Faso
🧪 DMF Preparation – Open & Closed Parts (Burkina Faso–Compliant)
We prepare complete, structured, and DPML-aligned DMF dossiers following the CTD format accepted for Burkina Faso submissions.
Applicant’s Part (Open Part)
Prepared for submission to DPML Burkina Faso / Local MA Holders / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– API Registration
– Finished Product Registration
– Import Authorization & Marketing Authorization
• CTD-structured documentation suitable for Burkina Faso and WAEMU-linked exports
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process and process flow diagrams
• Critical process parameters and in-process controls
• Raw materials, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality system (PQS)
• Stability data as per Zone IVb climatic conditions applicable to Burkina Faso
✅ Confidential data is disclosed strictly to DPML regulators and never to local applicants or distributors.
DMF Types Covered – Burkina Faso
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredients (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Burkina Faso
Already have a DMF for Burkina Faso?
We conduct Burkina Faso–specific DMF review and risk assessment based on:
• DPML technical expectations & inspection practices
• WAEMU GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely DPML deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 DPML Submission & Burkina Faso Regulatory Support
We provide hands-on support for DMF usage and filing in Burkina Faso, including:
• DPML submissions and clarifications
• API registration support
• Finished product registration support
• Import authorization & marketing authorization dossiers
• WAEMU export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Consistency across DMF, DPML dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Burkina Faso
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and post-approval variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• DPML-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – DPML Burkina Faso
Complete post-submission regulatory support for Burkina Faso, including:
• DPML deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with MA holder responses
• Coordination between manufacturer, MA holder, and DPML authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Burkina Faso?
🧪 In-depth knowledge of DPML & WAEMU regulatory pathways
🧪 Expertise in WAEMU GMP, WHO GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong DPML deficiency response experience
🧪 Seamless coordination with Burkina Faso MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Burkina Faso
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Burkina Faso
• Burkina Faso Public Health Code
• DPML Drug Registration Guidelines
• WAEMU/UEMOA Pharmaceutical Regulations
• WHO GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
Your Trusted Partner for DMF Excellence in Burkina Faso
Whether you are preparing a new DMF, updating an existing dossier, supporting a DPML Burkina Faso submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Burkina Faso market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
🗺️ BA/BE Study Workflow for Burkina Faso
Feasibility & Gap Assessment: Review of reference products, dissolution method suitability, and biowaiver potential.
Protocol Development: Preparation of ANRP-compliant BA/BE protocols and support for Ethics Committee approval.
Analytical Method Development: Validated LC-MS/MS method creation per ICH M10 and WHO TRS.
Clinical Execution: GCP-based subject recruitment, dosing, sampling, and medical monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical assessments.
Documentation & Submission: Preparation of ANRP-ready CSR, dissolution profile report, validation data, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers in Burkina Faso seeking ANRP approval
• CROs requiring outsourced BA/BE or analytical support
• Regulatory teams needing ANRP-compliant CTD/ACTD dossiers