🇲🇬 Bioavailability & Bioequivalence (BA/BE) Studies Services for Madagascar
AMM-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 the Agence du Médicament de Madagascar (AMM).
All studies strictly adhere to AMM Guidelines, ICH, WHO TRS, GCP, GLP, ensuring compliance for pharmaceutical submissions in Madagascar and international markets.
💊 Core Services for Madagascar (AMM) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by AMM.
• Volunteer Selection: Healthy volunteers or patients depending on therapeutic indication.
• Ethics Approval: Approval from a recognized Ethics Committee/IRB in Madagascar.
• Protocol Development: AMM-aligned BA/BE study protocols developed following ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic medicine approval, quality changes, and dossier variations in Madagascar.
• Dissolution Media: Pharmacopeial and biorelevant media.
• Similarity Assessment: f2 similarity factor analysis for dissolution comparison.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent dissolution models.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and AMM-supported scientific principles.
• IVIVC Models: Level A, B, and C correlation models.
• Predictive PK Modeling: Linking dissolution characteristics to in vivo outcomes for regulatory justification.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV analytical platforms.
• Validation: Conducted as per ICH M10, WHO TRS, and AMM-acceptable validation standards.
• Stability-Indicating Methods: Developed for APIs and finished dosage forms.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistics: Performed using WHO and ICH harmonized BE methodologies, acceptable to AMM.
• Study Powering: Sample-size and power determination to ensure statistical validity.
📑 AMM-Ready Regulatory Documentation
We prepare full regulatory submission packages for the Agence du Médicament de Madagascar (AMM), including:
• Clinical Study Protocol (Madagascar-compliant)
• Informed Consent Forms (ICF) meeting national ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for AMM regulatory submission
✨ Why Choose BioEquiGlobal for the Madagascar Market?
• Regulatory Alignment: All BE protocols, PK analyses, dissolution reports, and CTD documents tailored to AMM expectations.
• Global Standard Compliance: Operations follow GCP, GLP, WHO, and ICH guidelines with rigorous internal QA.
• Advanced Research Infrastructure: Accredited clinical units and high-precision analytical laboratories (including NABL-certified labs where applicable).
• International Dossier Expertise: CTD/ACTD submissions for AMM and other global authorities such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.
🗺️ BA/BE Study Workflow for Madagascar
Feasibility & Gap Assessment: Review of reference product requirements, dissolution methods, and biowaiver eligibility.
Protocol Development: Creation of AMM-compliant BA/BE protocols and facilitation of Ethics Committee approval.
Analytical Method Development: LC-MS/MS method design and validation following ICH M10 and WHO TRS guidelines.
Clinical Execution: GCP-based subject recruitment, dosing, sampling, and safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical assessment.
Documentation & Submission: Preparation of AMM-ready CSR, dissolution profile reports, validation documents, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers in Madagascar seeking AMM approval
• CROs requiring BA/BE studies or analytical outsourcing
• Regulatory teams needing AMM-compliant CTD/ACTD dossiers