🇲🇺 Bioavailability & Bioequivalence (BA/BE) Studies Services for Mauritius
Pharmacy Board–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory requirements of the Pharmacy Board of Mauritius.
All studies strictly comply with Mauritius regulatory guidelines, ICH, WHO TRS, GCP, and GLP, ensuring acceptability for national drug registration and international submissions.
💊 Core Services for Mauritius (Pharmacy Board) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel study designs approved by the Pharmacy Board.
• Volunteer Selection: Healthy volunteers or patient-based studies as required by product classification.
• Ethics Approval: Approval from a recognized Institutional Review Board (IRB)/Ethics Committee in Mauritius.
• Protocol Development: Mauritius guideline–aligned BA/BE protocols following ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic registration, variations, and product quality assessment.
• Dissolution Media: Biorelevant and pharmacopeial media used as per regulatory expectations.
• Similarity Factor: f2 similarity factor comparison for dissolution profiling.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared using WHO TRS, ICH Q6A, and Mauritius-relevant scientific criteria.
• IVIVC Modeling: Includes Level A, B, and C correlation models.
• Predictive PK Modeling: Supports BE justification and possible regulatory waivers.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV analytical platforms.
• Validation: Conducted according to ICH M10, WHO TRS, and Mauritius-accepted validation standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical formulations.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Conducted per ICH and WHO harmonized BE methodologies accepted in Mauritius.
• Sample Size & Power: Designed to ensure statistically robust BE outcomes.
📑 Mauritius-Ready Regulatory Documentation
We prepare complete drug registration documents in accordance with the Pharmacy Board of Mauritius, including:
• Clinical Study Protocol (Mauritius-compliant)
• Informed Consent Forms (ICF) following national ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for Mauritius regulatory submission
✨ Why Choose BioEquiGlobal for the Mauritius Market?
• Local Regulatory Expertise: BE protocols, PK analysis, dissolution profiling, and CTD dossiers tailored to Mauritius requirements.
• High International Standards: Fully compliant with GCP, GLP, ICH, and WHO guidelines with robust QA oversight.
• Advanced Clinical & Analytical Facilities: Accredited clinical units and high-performance analytical laboratories (including NABL-certified facilities where applicable).
• Global Dossier Capability: Preparation of CTD/ACTD submissions for Mauritius and global regulators such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and others.
🗺️ BA/BE Study Workflow for Mauritius
Feasibility & Gap Assessment: Evaluation of reference products, dissolution requirements, and biowaiver potential.
Protocol Development: Drafting Mauritius-compliant BA/BE protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method creation and validation according to ICH M10 and WHO TRS.
Clinical Execution: GCP-monitored recruitment, dosing, sampling, and safety evaluation.
Bioanalysis & PK Evaluation: PK calculations, QC verification, and BE statistical assessment.
Documentation & Submission: Preparation of Mauritius-ready CSR, dissolution profile, validation documentation, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers in Mauritius seeking product registration
• CROs requiring outsourced analytical or BA/BE services
• Regulatory teams requiring Pharmacy Board–compliant CTD/ACTD dossiers