🇯🇲 Bioavailability & Bioequivalence (BA/BE) Studies Services for Jamaica
MOHW / PRAB–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with Jamaica’s regulatory requirements under:
Ministry of Health & Wellness (MOHW)
Pharmaceutical & Regulatory Affairs Branch (PRAB)
Pharmacy Council of Jamaica
All studies strictly follow MOHW guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for pharmaceutical registration in Jamaica and international markets.
💊 Core Services for Jamaica (MOHW / PRAB) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose crossover and parallel BE study designs.
• Volunteer Selection: Healthy adult volunteers or patient groups where required.
• Ethics Approval: Mandatory approval from a Jamaica-based Institutional Review Board (IRB)/Ethics Committee recognized by MOHW.
• Protocol Development: Prepared per ICH E6 (R2) GCP, WHO TRS, and PRAB expectations.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic registration, product variations, and formulation evaluations.
• Dissolution Media: Pharmacopeial & biorelevant media suitable for Jamaica’s regulatory review.
• Similarity Factor: f2 similarity factor to compare dissolution profiles.
• Evaluation Approaches: WHO/ICH-compliant model-independent (f1, f2) and model-dependent dissolution analyses.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared based on WHO TRS and ICH Q6A, acceptable within Jamaica’s regulatory framework.
• IVIVC Models: Level A, B, and C correlation models.
• Predictive PK Modeling: Enhances regulatory justification and study design optimization.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV analytical platforms.
• Validation: Conducted per ICH M10 and WHO TRS, compatible with Jamaica’s regulatory expectations.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• Analysis: Non-compartmental PK analysis (NCA).
• Statistical BE Evaluation: Carried out using WHO/ICH standard methodologies.
• Sample Size & Power: Determined scientifically to ensure robust BE outcomes.
📑 Jamaica MOHW–Ready Regulatory Documentation
We prepare full regulatory documentation tailored for Jamaica’s medicines approval pathway, including:
• Clinical Study Protocol (Jamaica-compliant)
• Informed Consent Forms (ICF) per local ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted for Jamaica’s PRAB submission process
✨ Why Choose BioEquiGlobal for the Jamaican Market?
• Regulatory Insight: Expertise in Jamaica’s MOHW/PRAB medicines regulatory framework.
• Strict Compliance: GCP, GLP, WHO TRS, and ICH guidelines implemented with comprehensive quality systems.
• State-of-the-Art Infrastructure: Accredited clinical research facilities and advanced analytical laboratories (including NABL-certified labs).
• Global Submission Readiness: CTDs prepared for Jamaica and international agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Jamaica
Feasibility & Gap Assessment: Evaluation of reference products, dissolution requirements, and biowaiver feasibility.
Protocol Development: Drafting Jamaica-compliant BA/BE protocols and securing IRB/ethics approval.
Analytical Method Development: LC-MS/MS assay development & validation as per ICH M10 & WHO TRS.
Clinical Execution: GCP-supervised volunteer recruitment, dosing, PK sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and BE statistical evaluation.
Documentation & Submission: Preparation of MOHW-ready CSR, dissolution report, validation package, and CTD/ACTD modules.
Who We Support
• Pharmaceutical companies targeting the Jamaican and Caribbean market
• CROs requiring BA/BE outsourcing or analytical testing
• Regulatory teams needing PRAB-compliant CTD/ACTD dossiers