🇭🇰 Bioavailability & Bioequivalence (BA/BE) Studies Services for Hong Kong
Hong Kong Drug Office–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive BA/BE study services and Comparative Dissolution Profiling tailored to the regulatory framework of Hong Kong, governed by the Drug Office of the Department of Health and the Pharmacy and Poisons Board (PPB).
Our services fully align with ICH guidelines, WHO TRS, Hong Kong Drug Office requirements, and internationally accepted standards for supporting pharmaceutical companies in achieving HK-RPPS (Hong Kong Registration of Pharmaceutical Products and Substances) approvals.
💊 Our Core Services for Hong Kong Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Design: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by the Hong Kong Drug Office.
• Volunteer Selection: Healthy volunteers or patient-based studies in line with globally harmonized clinical research standards.
• Ethics Approval: Review and approval by a recognized Institutional Review Board (IRB) or Ethics Committee as required for Hong Kong submissions.
• Protocol Compliance: Protocols developed following ICH E6 (R2) GCP, WHO TRS, and BA/BE principles accepted by the Pharmacy and Poisons Board.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for registration and variation submissions under Hong Kong Drug Office guidance.
• Media: Test using biorelevant and pharmacopeial dissolution media.
• Analysis: Calculation of f2 similarity factor as recommended for dissolution equivalence demonstration.
• Comparison Methods: Model-independent (f1, f2) and model-dependent approaches for dissolution assessment.
IVIVC & Biowaiver Support
• Biowaiver Justification: BCS-based biowaiver preparation aligned with ICH, WHO TRS, and internationally recognized practices accepted by the Drug Office.
• IVIVC Modeling: Level A, B, and C correlations for biopharmaceutic evaluation.
• Predictive Performance: Application of dissolution–PK modeling to support regulatory submissions.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV methods suitable for Hong Kong BA/BE requirements.
• Validation: Conducted using ICH M10, WHO, and internationally accepted analytical validation standards.
• Stability Methods: Development of stability-indicating methods for APIs and finished drug products.
Pharmacokinetic (PK) Analysis
• PK Modeling: Non-compartmental PK analysis for all study types.
• Statistical BE Assessment: Bioequivalence calculations aligned with ICH and globally recognized criteria accepted by Hong Kong regulators.
• Study Design Optimization: Power and sample-size calculations for accurate BE demonstration.
📑 Hong Kong Drug Office–Ready Regulatory Documentation
We prepare complete documentation packages required for pharmaceutical product registration in Hong Kong:
• Clinical Study Protocol (ICH-compliant and Hong Kong–aligned)
• Informed Consent Forms (ICF) meeting IRB and Drug Office expectations
• Investigator Brochure
• Clinical Study Report (CSR) prepared per ICH and WHO specifications
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD modules specifically structured for Hong Kong’s Pharmaceutical Registration (HK-RPPS)
✨ Why Choose BioEquiGlobal for the Hong Kong Market?
• Regulatory Expertise: Study designs and documentation aligned with the Drug Office and PPB requirements, following ICH harmonization.
• Quality Assurance: QA-audited operations with strict adherence to GCP/GLP and internationally recognized quality systems.
• State-of-the-Art Infrastructure: Accredited clinical units and advanced analytical laboratories (including NABL-certified labs where applicable).
• Global Dossier Preparation: Support for submissions to Hong Kong, US FDA, EMA, TGA, MHRA, GCC, and other global authorities.
🗺️ Our BA/BE Study Workflow for Hong Kong
Feasibility & Regulatory Gap Assessment: Evaluation of reference drug requirements, biowaiver feasibility, and Hong Kong Drug Office submission criteria.
Protocol Development: Drafting of ICH-aligned and Hong Kong–appropriate BA/BE study protocols with IRB approval support.
Analytical Method Development: Validation of LC-MS/MS analytical methods per ICH M10 and international standards.
Clinical Study Execution: Controlled dosing, sampling, and monitoring under GCP-compliant conditions.
Bioanalysis & PK Assessment: Full analytical phase with QC validation, PK modeling, and bioequivalence statistical analysis.
Documentation & Submission: Preparation of DRA-ready CSR, validation data, dissolution reports, and CTD/ACTD submission modules for HK-RPPS.
Who We Support
• Pharmaceutical companies seeking Hong Kong drug registration (HK-RPPS)
• CROs and research centers requiring outsourced clinical or analytical support
• Regulatory teams needing Hong Kong Drug Office–compliant CTD/ACTD documentation