Analytical Method Validation Services – 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 dossiersEnsuring Accuracy. Compliance. Regulatory Confidence for Mauritius Regulatory Submissions
VALIDEX, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Analytical Method Validation (AMV) services for Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Finished Products, fully compliant with Mauritius regulatory requirements.
We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Mauritius with Pharmacy Board of Mauritius–compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of regulatory queries for product registration, marketing authorization, manufacturing/import approvals, and export dossiers.
Our Core Expertise – Mauritius Focus
VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Pharmacy Board of Mauritius (PBM) under the Ministry of Health & Wellness, Republic of Mauritius.
✅ Assay Method Validation
• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by PBM Mauritius
• Accuracy, precision, linearity, robustness, and specificity
• USP / BP / EP / IP harmonized analytical methods
✅ Impurities Method Validation
• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with PBM & WHO expectations
• Compliance with ICH Q3A / Q3B and pharmacopoeial impurity limits
✅ Dissolution Method Validation
• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with PBM product registration and post-approval variation requirements
✅ Residual Solvents Method Validation
• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C adopted by PBM Mauritius
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, and precision
Products Covered – Mauritius
✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, powders, sachets)
✅ Injectable formulations (sterile & non-sterile)
✅ Semi-solid & liquid dosage forms
✅ Modified-release and controlled-release products
Regulatory Compliance – Mauritius
All Analytical Method Validation activities are conducted in accordance with:
• ICH Q2 (R1 / R2)
• Pharmacy Board of Mauritius Registration Guidelines
• Dangerous Drugs Act & Pharmacy Act (Mauritius)
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by PBM)
• USP / BP / EP Pharmacopoeial Standards
Post-Submission Regulatory Support – Mauritius
VALIDEX provides complete PBM query management, including:
✅ Responses to PBM deficiency letters and technical evaluation queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during PBM dossier reviews, inspections, and audits
Why Choose VALIDEX for Mauritius?
✔ Strong understanding of PBM regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Mauritius
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines
✔ Strict confidentiality and data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd
Our Deliverables – Mauritius
• Analytical Method Validation Protocols (PBM-compliant)
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / Non-CTD summary documents for PBM submissions
• Regulatory query response packages
• Method transfer, verification, and re-validation documentation
Industries We Serve in Mauritius
• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers, distributors, and MAHs
• Regulatory and dossier consulting firms
National & Export Support – Mauritius
VALIDEX supports Analytical Method Validation for:
• Mauritius domestic product registration (PBM)
• Manufacturing and import authorization applications
• Export dossiers prepared for PBM-regulated and WHO-referenced markets
Partner with VALIDEX – Mauritius
Achieve PBM-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Mauritius.