🇲🇾 Bioavailability & Bioequivalence (BA/BE) Studies Services for Malaysia
NPRA/DCA-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory standards of the National Pharmaceutical Regulatory Agency (NPRA) and the Drug Control Authority (DCA) Malaysia.
All studies strictly follow GCP, GLP, ICH, WHO TRS, and Malaysia’s Malaysian Guidelines for Bioequivalence Studies, ensuring full compliance for national drug registration as well as regional and international submissions.
💊 Core Services for Malaysia (NPRA/DCA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose studies; crossover and parallel designs accepted by NPRA/DCA.
• Volunteer Selection: Healthy volunteers or patient groups based on study requirements and NPRA guidance.
• Ethics Approval: Approval from a registered Medical Research & Ethics Committee (MREC) or Institutional Ethics Committee in Malaysia.
• Protocol Development: NPRA-aligned protocols based on ICH E6 (R2) GCP, WHO TRS, and ASEAN guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Essential for generic drug registration and post-approval variations under NPRA requirements.
• Dissolution Media: Biorelevant and pharmacopeial media as recommended by NPRA and ASEAN guidelines.
• Similarity Factor: Calculation of f2 similarity factor for dissolution comparison.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent dissolution analyses.
IVIVC & Biowaiver Support
• BCS Biowaiver: Prepared following WHO TRS, ICH Q6A, and NPRA-recognized biowaiver criteria.
• IVIVC Models: Level A, B, and C models to support predictability.
• Dissolution–PK Modeling: Predictive performance evaluation to support regulatory justification.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV methods for high-sensitivity drug quantification.
• Validation: Conducted per ICH M10, WHO TRS, and NPRA-accepted validation standards.
• Stability Studies: Development of stability-indicating methods for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA) used for BA/BE evaluation.
• BE Statistics: Statistical comparison per ICH, WHO, and NPRA bioequivalence requirements.
• Study Powering: Sample size calculations and study design optimization.
📑 NPRA/DCA-Ready Regulatory Documentation
We prepare complete documentation required for pharmaceutical registration with Malaysia’s Drug Control Authority (DCA) and NPRA, including:
• Clinical Study Protocol (Malaysia-compliant)
• Informed Consent Forms (ICF) per Malaysian ethical guidelines
• Investigator Brochure
• Clinical Study Report (CSR) structured as per ICH and NPRA requirements
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for NPRA drug registration
✨ Why Choose BioEquiGlobal for the Malaysian Market?
• Malaysia-Focused Expertise: BA/BE study designs, dissolution approaches, and documentation aligned with NPRA/DCA standards.
• Strict Quality Compliance: GCP-, GLP-, and WHO-driven operations with strong SOP-based QA oversight.
• High-End Infrastructure: Accredited clinical units and precision analytical laboratories (including NABL-certified labs where applicable).
• Global Regulatory Experience: Dossiers prepared for NPRA as well as US FDA, EMA, MHRA, GCC, TGA, ASEAN, and African regulatory agencies.
🗺️ BA/BE Study Workflow for Malaysia
Feasibility & NPRA Gap Assessment: Evaluation of reference product availability in Malaysia, dissolution method suitability, and BCS biowaiver eligibility.
Protocol Development: Drafting of NPRA/DCA-compliant BA/BE protocols and facilitating MREC/IRB approvals.
Analytical Method Development: LC-MS/MS method design and validation following ICH M10 and NPRA requirements.
Clinical Study Execution: GCP-monitored volunteer dosing, sample collection, and medical supervision.
Bioanalysis & PK Assessment: QC-verified bioanalysis, PK modeling, and BE statistical evaluation.
Documentation & Submission: Preparation of NPRA-ready CSR, analytical reports, dissolution profiles, and CTD/ACTD dossier modules.
Who We Support
• Malaysian pharmaceutical manufacturers seeking NPRA/DCA drug registration
• CROs requiring outsourced BA/BE or analytical services
• Regulatory affairs teams needing NPRA-compliant CTD/ACTD dossiers