🇲🇱 Bioavailability & Bioequivalence (BA/BE) Studies Services for Mali
ANMPS-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory requirements of Mali’s Agence Nationale du Médicament et des Produits de Santé (ANMPS).
All studies strictly follow ANMPS guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for Mali’s pharmaceutical registration requirements and international submissions.
💊 Core Services for Mali (ANMPS) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by ANMPS.
• Volunteer Selection: Healthy volunteers or patient populations based on therapeutic class.
• Ethics Approval: Required approval from a recognized Comité d’Éthique/IRB in Mali.
• Protocol Development: ANMPS-aligned study protocols developed according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic medicine registration, dossier variations, and equivalence assessments.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Assessment: f2 similarity factor to compare dissolution curves of test vs. reference formulations.
• Evaluation Models: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared in line with WHO TRS, ICH Q6A, and ANMPS scientific expectations.
• IVIVC Modeling: Level A, B, and C correlation models for predicting in vivo results.
• Predictive PK Analysis: Supports regulatory justification for BE waiver or enhancement.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV methods for accurate bioanalysis.
• Validation: Performed according to ICH M10, WHO TRS, and validation criteria accepted by ANMPS.
• Stability-Indicating Methods: Developed for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistics: Conducted using ICH- and WHO-aligned statistical approaches recognized by ANMPS.
• Sample Size & Study Power: Determined to ensure conclusive BE demonstration.
📑 ANMPS-Ready Regulatory Documentation
We prepare full drug registration documentation tailored to Mali’s Agence Nationale du Médicament et des Produits de Santé (ANMPS), including:
• Clinical Study Protocol (Mali-compliant)
• Informed Consent Forms (ICF) following national ethical guidelines
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for ANMPS submissions
✨ Why Choose BioEquiGlobal for the Malian Market?
• Regulatory Alignment: BE protocols, PK reports, dissolution comparisons, and dossier formats designed to satisfy ANMPS requirements.
• High Global-Standard Compliance: All operations meet GCP, GLP, WHO TRS, and ICH guidelines, supported by strong QA oversight.
• Advanced Clinical & Analytical Capability: Accredited clinical units and precision analytical labs (including NABL-certified facilities where applicable).
• International Dossier Expertise: Preparation of CTD/ACTD submissions for Mali and other authorities such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.
🗺️ BA/BE Study Workflow for Mali
Feasibility & Gap Assessment: Review of available reference products, dissolution method requirements, and biowaiver eligibility.
Protocol Development: Drafting ANMPS-compliant BA/BE protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method development and validation per ICH M10 and WHO TRS.
Clinical Execution: GCP-supervised recruitment, dosing, sampling, and medical oversight.
Bioanalysis & PK Evaluation: PK computation, QC checks, and statistical BE evaluation.
Documentation & Submission: Preparation of ANMPS-ready CSR, dissolution profiles, validation documentation, and CTD/ACTD modules.
Who We Support
• Malian pharmaceutical manufacturers seeking ANMPS approval
• CROs requiring BA/BE outsourcing or analytical method development
• Regulatory teams needing ANMPS-compliant CTD/ACTD dossiers