🇧🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Brunei

BDMCA / MoH Brunei–Compliant BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies and Comparative Dissolution Profiling, fully aligned with the regulatory requirements of Brunei Darussalam Medicines Control Authority (BDMCA) and the Pharmaceutical Services Department (PSD) under the Ministry of Health.

Brunei adopts a harmonized ASEAN pharmaceutical regulatory framework, and therefore recognizes:

• BDMCA Guidelines for Medicinal Product Registration

• ASEAN Guidelines for the Conduct of Bioequivalence Studies

• WHO TRS Bioequivalence Guidelines

• ICH Guidelines (E6 R2, Q2, Q6A, M10)

• EMA Bioequivalence Guideline (accepted as scientific reference)

• GCP, GLP & GMP international quality standards

• USP / Ph. Eur. dissolution standards

This ensures BE data generated by BioEquiGlobal is accepted in Brunei and across ASEAN countries, including Singapore, Malaysia, Thailand, Indonesia, Vietnam & the Philippines.

💊 Core BA/BE Services for Brunei (ASEAN & BDMCA-Aligned)

Clinical BA/BE Studies (Human)

• Conducted per BDMCA, ASEAN, WHO & ICH standards.
• Single-dose & multiple-dose (crossover/parallel) BE studies.
• Healthy volunteer or patient-specific PK studies.
• Ethical approvals following ICH-GCP and internationally accepted frameworks.
• Protocols structured as per ASEAN BE Guidelines & ICH E6 (R2).

Comparative Dissolution Profiling (CDP)

• Required for generic drug submissions in Brunei.
• Dissolution based on USP, Ph. Eur., ASEAN and biorelevant media.
• Similarity factor (f2) dissolution comparison.
• Model-independent and kinetic dissolution evaluations.

IVIVC & Biowaiver Support

• ASEAN- and WHO-aligned BCS-based biowaiver justification.
• Level A/B/C IVIVC PK–dissolution modeling.
• Eligible for BCS Class I & III products per ASEAN guidelines.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV bioanalytical method development.
• Full validation as per ICH M10, recognized by the BDMCA.
• Stability-indicating assays for APIs & finished products.
• Accuracy, precision, linearity, selectivity & stability assessments.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK computations (AUC, Cmax, Tmax, t½).
• ASEAN-standard BE acceptance limits: 90% CI between 80–125%.
• Scaled BE methodology for Highly Variable Drugs (HVDs) where applicable.
• Sample-size and power optimization per ASEAN/ICH statistics.

📑 Brunei (BDMCA)–Ready CTD Documentation

We prepare complete dossier documentation suitable for Brunei 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
• ASEAN-CTD / Brunei-CTD Modules 1–5, including:

• Brunei-specific Module 1 requirements

• Generic product submission requirements

• Stability and quality documentation

• BA/BE justification for product approval

✨ Why Choose BioEquiGlobal for Brunei?

• Aligned with BDMCA / ASEAN BE Requirements: Ensures complete regulatory acceptability across Brunei & ASEAN.
• GCP/GLP/GMP-Compliant Operations: Global-standard quality for defensible BE data.
• BE Expertise for Complex Generics: Modified-release (MR), HVDs, injectables, inhalation, ophthalmic, topical & hormone products.
• Ideal for ASEAN + Global Market Entry: Documents structured to support Brunei, Malaysia, Singapore, Indonesia & the wider region.
• End-to-End Service Model: From feasibility analysis to PK/BE evaluation and final CTD dossier preparation.

🗺️ BA/BE Study Workflow for Brunei (BDMCA Submission)

1. Feasibility & ASEAN BE Guideline Mapping
   (Reference product identification, biowaiver eligibility, protocol strategy)

2. Protocol Development & Ethics Compliance
   (ICH-GCP–aligned documentation)

3. Analytical Method Development & Validation
   (ICH M10-compliant LC-MS/MS/HPLC method validation)

4. Clinical Study Execution
   (Volunteer recruitment, dosing & PK sampling under GCP)

5. Bioanalysis & PK/BE Evaluation
   (NCA analysis, BE statistical calculations, scaled BE if applicable)

6. Brunei CTD / ASEAN-CTD Documentation Preparation
   (CSR, CDP, validation reports & full CTD Modules 1–5)

Who We Support in Brunei & Across ASEAN

• Pharmaceutical manufacturers targeting Brunei or ASEAN markets
• ASEAN-based MAH applicants
• CROs outsourcing analytical or BA/BE studies
• Export-driven pharma companies
• Innovators reformulating for ASEAN compliance
• Specialty pharma & biotech organizations