BMRx – Global Batch Manufacturing Record (BMR) 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

1. Feasibility & Gap Assessment: Review of available reference products, dissolution method requirements, and biowaiver eligibility.

2. Mali MOH–Aligned | WHO GMP Compliant | Inspection-Ready

   BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Batch Manufacturing Record (BMR) Preparation & Review Services for pharmaceutical and regulated-industry manufacturers and suppliers serving the Malian market and regional West African exports.

   Since 2008, BMRx has supported manufacturers across Africa and global markets with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with the Ministry of Health (MOH) Mali / National Medicines Regulatory Authority, WHO GMP, and global inspection readiness.

   Who We Serve in Mali

   We work with Mali-based and Mali-focused organizations involved in:

   • Manufacturing for the Mali domestic market (MOH / NMRA)
   • Importation, local packaging & secondary manufacturing
   • Export to ECOWAS & WAEMU (UEMOA) markets
   • Contract manufacturing (CMOs / CDMOs)
   • Technology transfer & scale-up projects
   • MOH inspections, WHO audits & donor / customer assessments

   Our BMR Services for Mali Market Products

   ✅ BMR Preparation

   We prepare product-specific, process-driven BMRs aligned with:

   • Mali MOH GMP requirements
   • WHO GMP Guidelines
   • US FDA cGMP (21 CFR Parts 210 & 211)
   • EU GMP Guidelines
   • PIC/S GMP Requirements

   Key Features:
   • Non-generic, facility-specific BMRs
   • Operator-friendly & shop-floor executable formats
   • Clear in-process controls, yields & critical parameters
   • Inspection-ready documentation acceptable to MOH, WHO & regional authorities

   ✅ BMR Review & GMP Compliance Check

   Independent technical and GMP review of existing BMRs to identify:

   • Missing Mali MOH / WHO GMP elements
   • Documentation & data-integrity gaps
   • Inspection-critical weaknesses
   • Non-alignment with ECOWAS & donor-procurement expectations

   Deliverables include clear, implementable remediation recommendations.

   ✅ Regulatory Query & Inspection Support

   Support during:

   • Mali MOH post-submission queries
   • MOH GMP inspections & follow-ups
   • WHO audits & donor / procurement inspections
   • Export-market regulatory reviews

   Including:
   • Authority query responses
   • Inspection observation remediation
   • CAPA-linked BMR corrections

   ✅ Gap Assessment & Remediation

   Comprehensive gap analysis of existing BMRs against:

   • Mali MOH GMP requirements
   • WHO GMP expectations
   • PIC/S & export-market MOH requirements

   With practical, floor-ready corrective actions suitable for Mali-linked manufacturing and supply environments.

   ✅ Customized BMR Templates

   Provision of ready-to-use, regulator-accepted BMR templates, customized based on:

   • Dosage form
   • Equipment & batch size
   • Manufacturing / packaging process
   • Facility layout & utilities
   • Target domestic, ECOWAS & export markets

   Our Global Experience (Supporting Mali from India)

   • 3000+ BMRs prepared & reviewed
   • Operational since 2008
   • Experience across:
   – Mali
   – West & Central Africa (ECOWAS / UEMOA)
   – Middle East
   – Asia
   – Europe
   – LATAM

   Product Categories Supported:
   • Finished dosage forms
   • APIs & intermediates
   • Herbal & traditional medicines
   • Nutraceuticals & food ingredients
   • Cosmetics & personal care
   • Chemicals & disinfectants

   Regulatory Interaction Experience With:
   • Mali Ministry of Health / National Medicines Authorities
   • WHO
   • US FDA
   • EU Authorities
   • PIC/S Regulators

   Regulatory Standards Followed

   All BMR documentation is prepared in accordance with:

   • Mali MOH GMP Guidelines
   • WHO GMP
   • US FDA cGMP (21 CFR 210 & 211)
   • EU GMP Guidelines
   • PIC/S GMP Requirements
   • ICH Q7 / Q8 / Q9 / Q10 (where applicable)
   • Country-specific MOH & donor-procurement expectations

   Industries We Support in Mali

   • Pharmaceutical Finished Dosage Forms
   • APIs & Bulk Drugs
   • Herbal & Traditional Medicines
   • Nutraceuticals & Food Ingredients
   • Cosmetics & Personal Care
   • Industrial & Specialty Chemicals

   Why Mali Market Companies Choose BMRx

   • 🇲🇱 Strong understanding of Mali MOH & WHO GMP expectations
   • 🌍 Export- & donor-oriented BMRs accepted across West Africa
   • 📋 Inspection-ready & auditable documentation
   • 🔍 Reduced regulatory & procurement observations
   • 🧠 Integrated technical, GMP & regulatory expertise
   • 🛠️ Non-generic, process-specific BMRs
   • 🔒 Confidential, professional & deadline-driven delivery
   • 👷 Operator-friendly formats for reliable execution

   How We Initiate a BMR Project

   To initiate BMR preparation or review, we typically require:

   • Product & formulation details
   • Manufacturing / packaging process & flow diagram
   • Equipment list & batch size
   • Target markets / procurement channels
   • Existing BMRs (if available)

   Based on this, we provide:

   • Customized technical scope
   • Clear timelines
   • Transparent commercial proposal

   BMRx

   Batch Manufacturing Records. Built for Compliance. Ready for Inspection.
   Supporting Mali market products for regional and global regulatory success.

3. Analytical Method Development: LC-MS/MS method development and validation per ICH M10 and WHO TRS.

4. Clinical Execution: GCP-supervised recruitment, dosing, sampling, and medical oversight.

5. Bioanalysis & PK Evaluation: PK computation, QC checks, and statistical BE evaluation.

6. 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