🇬🇭 Bioavailability & Bioequivalence (BA/BE) Studies Services for Ghana
FDA Ghana–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory requirements of the Food and Drugs Authority (FDA Ghana).
All studies strictly follow FDA Ghana Guidelines, ICH, WHO TRS, GCP, and GLP, ensuring regulatory acceptance for Ghanaian drug registration and international markets.
💊 Core Services for Ghana (FDA Ghana) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel models accepted by FDA Ghana.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on therapeutic category.
• Ethics Approval: Approval required from a recognized Institutional Review Board (IRB)/Ethics Committee in Ghana.
• Protocol Development: FDA Ghana–aligned protocols developed according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic registration, variations, and quality assessment under FDA Ghana guidelines.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Assessment: f2 similarity factor used to compare dissolution curves.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent dissolution models.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared following WHO TRS, ICH Q6A, and frameworks accepted by FDA Ghana.
• IVIVC Models: Level A, B, and C correlation models for predicting in vivo behavior.
• Predictive PK Modeling: Supports regulatory justification for biowaiver and BE decisions.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV for high-sensitivity drug quantification.
• Validation: Conducted according to ICH M10, WHO TRS, and FDA Ghana–accepted standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Analysis Type: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Conducted following WHO and ICH harmonized BE methods recognized by FDA Ghana.
• Sample Size & Power Determination: Designed to ensure conclusive BE outcomes.
📑 FDA Ghana–Ready Regulatory Documentation
We prepare full regulatory documentation aligned with FDA Ghana pharmaceutical registration requirements, including:
• Clinical Study Protocol (Ghana-compliant)
• Informed Consent Forms (ICF) aligned with national ethical guidelines
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO structures
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for FDA Ghana submissions
✨ Why Choose BioEquiGlobal for the Ghanaian Market?
• Ghana Regulatory Expertise: Protocols, PK analyses, dissolution profiles, and CTD modules tailored to FDA Ghana requirements.
• High Global-Standard Compliance: Operations conducted under GCP, GLP, WHO TRS, and ICH guidelines with rigorous QA systems.
• State-of-the-Art Facilities: Accredited clinical units and high-precision analytical laboratories (including NABL-certified facilities).
• International Submission Capability: CTD/ACTD dossiers prepared for FDA Ghana and global regulators including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and others.
🗺️ BA/BE Study Workflow for Ghana
Feasibility & Regulatory Assessment: Review of Ghanaian reference products, dissolution method suitability, and biowaiver potential.
Protocol Development: Preparation of FDA Ghana–compliant BA/BE protocols and facilitation of Ethics Committee approval.
Analytical Method Development: LC-MS/MS method creation and validation as per ICH M10 and WHO TRS.
Clinical Execution: GCP-monitored subject recruitment, dosing, sampling, and medical supervision.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE assessment.
Documentation & Submission: Preparation of FDA Ghana–ready CSR, dissolution report, validation packages, and CTD/ACTD modules.
Who We Support
• Ghanaian pharmaceutical manufacturers seeking FDA Ghana approval
• CROs needing outsourced BA/BE or analytical support
• Regulatory teams requiring FDA Ghana–compliant CTD/ACTD dossiers