🇲🇻 Bioavailability & Bioequivalence (BA/BE) Studies Services for Maldives
MFDA Maldives–Aligned BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers complete Bioavailability (BA) and Bioequivalence (BE) study services, along with Comparative Dissolution Profiling, customized for regulatory submissions to the Maldives Food and Drug Authority (MFDA).
Maldives relies heavily on international and harmonized regulatory frameworks, therefore our BE studies comply with:
MFDA Requirements for Pharmaceutical Product Registration
WHO TRS Bioequivalence Guidelines
ICH Guidelines (E6 R2, Q2, Q6A, M10)
ASEAN Guidelines for BA/BE (accepted as reference for generics)
EMA BE Guideline (scientific reference)
GCP, GLP & GMP global quality frameworks
USP / Ph. Eur. dissolution standards
This ensures the BE study data generated is suitable, acceptable, and review-ready for the Maldives regulatory authority.
💊 Core BA/BE Services for Maldives (MFDA-Aligned)
Clinical BA/BE Studies (Human)
• Conducted per MFDA, WHO TRS, ICH & international BE guidelines.
• Single-dose & multiple-dose BE studies (crossover or parallel).
• Healthy volunteer & patient-based PK studies depending on product class.
• Ethical approvals aligned with ICH-GCP requirements.
• Protocols designed per ICH E6 (R2) and WHO/ASEAN BE principles.
Comparative Dissolution Profiling (CDP)
• Required for generic submissions in Maldives.
• Dissolution using USP, Ph. Eur., WHO, and biorelevant media.
• Similarity factor (f2) for dissolution equivalence assessment.
• Kinetic & model-independent dissolution profile analysis.
IVIVC & Biowaiver Support
• BCS-based biowaiver justification aligned with MFDA + WHO + ICH Q6A.
• Level A/B/C IVIVC modeling to correlate PK with dissolution.
• Suitable for BCS Class I & III drug products.
Analytical Method Development & Validation
• LC-MS/MS & HPLC-UV analytical method development.
• Validation as per ICH M10, accepted by MFDA and global agencies.
• Stability-indicating analytical procedures for APIs & formulations.
• Validation parameters: accuracy, precision, linearity, selectivity & stability.
Pharmacokinetic (PK) & Bioequivalence Statistical Analysis
• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• BE acceptance limits: 90% CI within 80–125%.
• Scaled BE methodology for Highly Variable Drugs (HVDs) where appropriate.
• Power & sample-size calculations per ICH and WHO recommendations.
📑 MFDA Maldives–Ready CTD Documentation
We prepare complete dossier documentation suitable for Maldives submissions:
• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) – ICH E3 format
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• MFDA / ACTD / CTD Modules 1–5, including:
Maldives-specific Module 1 administrative requirements
Generic drug application documents
Stability and pharmaceutical quality evidence
Bioequivalence justification for product approval
✨ Why Choose BioEquiGlobal for Maldives?
• Aligned with MFDA Standards: Ensures acceptance of BE studies for generic product approvals.
• WHO/ICH-Recognized Data Quality: Ideal for global and regional regulatory acceptance.
• Support for Simple & Complex Generics: MR products, ophthalmic, inhalation, topicals, injectables & HVDs.
• End-to-End BE Service Model: From feasibility, protocol development, clinical conduct, bioanalysis, to CTD dossier preparation.
• Ideal for Indian, Asian & Global Export Markets: BE data structured to support approvals in Maldives and nearby regions.
🗺️ BA/BE Study Workflow for Maldives (MFDA Submission)
Feasibility & WHO/ASEAN BE Requirement Mapping
(Reference selection, biowaiver suitability, guideline alignment)Protocol Development & Ethics Approval (ICH-GCP)
(Aligned with international BE study structures)Analytical Method Development & Validation
(ICH M10-compliant LC-MS/MS validation)Clinical BA/BE Study Execution
(Volunteer recruitment, dosing & PK sampling under GCP)Bioanalysis & PK/BE Evaluation
(NCA, BE statistical calculations, scaled BE for HVDs where applicable)MFDA/CTD Documentation Preparation
(CSR, CDP, validation package & CTD Modules for submission)
Who We Support in Maldives & Neighboring Regions
• Pharmaceutical manufacturers targeting Maldives
• Export-oriented pharma from India, Asia & Middle East
• ACTD/CTD applicants for generic medicines
• CROs outsourcing analytical or clinical BA/BE components
• Biotech & specialty pharma organizations
• R&D teams reformulating medicines for island markets