🇬🇲 Bioavailability & Bioequivalence (BA/BE) Studies Services for The Gambia
MCA Gambia–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 Medicines Control Agency (MCA) of The Gambia.
All studies strictly follow ICH, WHO TRS, GCP, GLP, and MCA regulatory expectations, ensuring suitability for national drug registration and global submissions.
💊 Core Services for Gambia (MCA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs recognized by MCA.
• Volunteer Selection: Healthy volunteers or patient-based studies based on therapeutic class.
• Ethics Approval: Required approval from a Gambian Institutional Review Board (IRB)/Ethics Committee.
• Protocol Development: MCA-aligned BA/BE protocols developed according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for generic medicine registration and post-approval variations.
• Dissolution Media: Biorelevant and pharmacopeial dissolution media.
• Similarity Factor: f2 similarity factor to evaluate similarity between test and reference dissolution profiles.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared in accordance with WHO TRS, ICH Q6A, and MCA-recognized scientific principles.
• IVIVC Modeling: Level A, B, and C predictive models.
• Predictive PK Modeling: Supports regulatory justification for biowaiver eligibility.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV bioanalytical systems.
• Validation: Conducted according to ICH M10, WHO TRS, and MCA-accepted validation standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceuticals.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Follows ICH, WHO, and globally harmonized BE methods recognized by MCA.
• Sample Size & Power: Designed using accepted international BE statistical principles.
📑 MCA-Ready Regulatory Documentation
We prepare complete regulatory documentation aligned with The Gambia’s Medicines Control Agency (MCA), including:
• Clinical Study Protocol (Gambia-compliant)
• Informed Consent Forms (ICF) following Gambian ethics regulations
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for MCA submission
✨ Why Choose BioEquiGlobal for the Gambian Market?
• Local Regulatory Expertise: Protocols, PK analyses, dissolution testing, and dossier preparation tailored to MCA requirements.
• High Compliance Standards: GCP-, GLP-, WHO-, and ICH-aligned operational systems with strong internal QA.
• Advanced Facilities: Accredited clinical units and precision analytical laboratories (including NABL-certified labs where applicable).
• Global Dossier Capability: Preparation of CTD/ACTD dossiers for MCA and other regulatory authorities such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and more.
🗺️ BA/BE Study Workflow for Gambia
Feasibility & Gap Assessment: Review of reference products in Gambia, dissolution requirements, and biowaiver eligibility.
Protocol Development: Preparation of MCA-compliant BA/BE protocols and support for Ethics Committee approval.
Analytical Method Development: LC-MS/MS method design and validation per ICH M10 and WHO TRS.
Clinical Execution: GCP-based volunteer recruitment, dosing, sample collection, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and BE statistical evaluation.
Documentation & Submission: Delivery of MCA-ready CSR, dissolution reports, validation data, and CTD/ACTD modules.
Who We Support
• Gambian pharmaceutical manufacturers seeking MCA approval
• CROs requiring BA/BE outsourcing or analytical support
• Regulatory teams needing MCA-compliant CTD/ACTD dossiers