🇫🇯 Bioavailability & Bioequivalence (BA/BE) Studies Services for Fiji
FMA–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory framework of Fiji’s:
Fiji Medicines Authority (FMA)
Ministry of Health & Medical Services (MoHMS), Republic of Fiji
All studies comply with FMA regulatory requirements, WHO TRS, ICH guidelines, GCP, and GLP, ensuring suitability for Fiji’s pharmaceutical registration pathway and international submissions.
💊 Core Services for Fiji (FMA / MoHMS) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BA/BE studies using crossover or parallel models.
• Volunteer Selection: Healthy adult volunteers or specific patient groups where required.
• Ethics Approval: Mandatory approval from a Fiji National Health Research Ethics Committee (FNHRERC) or institutional IRB.
• Protocol Development: Aligned with ICH E6 (R2) GCP, WHO TRS, and FMA expectations.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic registration, variation filings, and pharmaceutical equivalence evaluation.
• Dissolution Media: Standard pharmacopeial & biorelevant media.
• Similarity Factor: f2 similarity factor used to compare dissolution curves.
• Evaluation Approaches: Includes both model-independent (f1, f2) and model-dependent methods.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared based on WHO TRS and ICH Q6A, acceptable within FMA regulatory review.
• IVIVC Models: Level A, B, and C IVIVC correlation modeling.
• Predictive PK Modeling: Used to support scientific justification for biowaiver submissions.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV analytical platforms.
• Validation: Conducted per ICH M10 and WHO TRS guidelines, suitable for Fiji’s regulatory requirements.
• Stability-Indicating Methods: Developed for APIs and finished dosage forms.
Pharmacokinetic (PK) Analysis
• PK Analysis: Non-compartmental analysis (NCA).
• BE Statistics: Conducted per ICH and WHO harmonized BE evaluation standards.
• Sample Size & Power: Scientifically justified for conclusive BE outcomes.
📑 Fiji FMA–Ready Regulatory Documentation
We provide complete regulatory documentation tailored to Fiji’s MoHMS/FMA system, including:
• Clinical Study Protocol (FMA-compliant)
• Informed Consent Forms (ICF) per Fiji ethical guidelines
• 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 Fiji regulatory submission
✨ Why Choose BioEquiGlobal for the Fijian Market?
• FMA Regulatory Expertise: All BE protocols, dissolution studies, and CTD dossiers customized to Fiji’s regulatory expectations.
• International Standards Compliance: GCP, GLP, WHO TRS, and ICH adherence supported by strong QA frameworks.
• Advanced Infrastructure: Accredited clinical facilities and modern analytical laboratories (including NABL-certified labs).
• Global Submission Competence: CTDs prepared for Fiji and major regulatory agencies (US FDA, EMA, MHRA, TGA, Medsafe, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Fiji
Feasibility & Gap Assessment: Reference product review, dissolution suitability, and biowaiver potential assessment.
Protocol Development: Drafting Fiji-compliant BA/BE study protocols and coordinating ethics approval (FNHRERC).
Analytical Method Development: LC-MS/MS assay development & validation per ICH M10 and WHO TRS.
Clinical Study Execution: GCP-supervised dosing, sample collection, monitoring, and subject safety evaluation.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE testing.
Documentation & Submission: Preparation of FMA-ready CSR, dissolution report, validation documents, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Fiji and Pacific Island regulatory pathways
• CROs requiring BE or analytical outsourcing
• Regulatory teams needing FMA-ready CTD/ACTD dossiers