🇧🇭 Bioavailability & Bioequivalence (BA/BE) Studies Services for Bahrain

NHRA Bahrain–Compliant BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA) and Bioequivalence (BE) study services, as well as Comparative Dissolution Profiling, designed specifically for regulatory submissions to NHRA – National Health Regulatory Authority of Bahrain.

Bahrain follows a harmonized Gulf regulatory approach and relies on:

• NHRA Bahrain Guidelines for Registration of Pharmaceutical Products

• GCC-DR (Gulf Centralized Registration) Bioequivalence Requirements

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

• WHO TRS for BE studies

• EMA BE Guideline (accepted as scientific reference)

• GCP, GLP & GMP Quality Frameworks

• USP / Ph. Eur. Dissolution Standards

This ensures BA/BE data generated by BioEquiGlobal is fully acceptable to Bahrain and other GCC countries.

💊 Core BA/BE Services for Bahrain (NHRA-Aligned)

Clinical BA/BE Studies (Human)

• Conducted per NHRA, GCC-DR, WHO, ICH & EMA-aligned BIOE guidelines.
• Single-dose & multiple-dose (crossover/parallel) BE studies.
• Healthy volunteer studies; patient-based PK studies where required.
• Ethics approval following international ICH-GCP requirements.
• Protocol preparation aligned with ICH E6 (R2) & GCC/NHRA BE criteria.

Comparative Dissolution Profiling (CDP)

• Mandatory for generic drug registration in Bahrain.
• Dissolution testing using USP, Ph. Eur., and biorelevant media.
• Similarity factor (f2) analysis for profile comparison.
• Kinetic (model-dependent) and model-independent profile comparisons.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification compliant with NHRA + GCC + ICH Q6A.
• Level A/B/C IVIVC modeling to correlate dissolution with PK outcomes.
• Suitable for BCS Class I & III biowaiver pathways.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV analytical method development and validation.
• Fully validated per ICH M10, accepted by NHRA & GCC authorities.
• Stability-indicating methods for APIs & finished dosage products.
• Includes accuracy, precision, linearity, selectivity & stability.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• GCC-standard BE acceptance criteria: 90% CI within 80–125%.
• Scaled BE methodology for Highly Variable Drugs (HVDs).
• Power analysis & sample-size optimization per GCC/ICH norms.

📑 NHRA Bahrain–Ready Regulatory Documentation

We prepare comprehensive documentation packages for Bahrain:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 1–5, including:

• Bahrain/NHRA Module 1 requirements

• GCC-DR–aligned generic medicine dossier

• Stability & quality documentation for registration

✨ Why Choose BioEquiGlobal for Bahrain?

• NHRA & GCC-Aligned Expertise: Ensures approval-readiness for Bahrain and all GCC countries (Saudi Arabia, UAE, Oman, Qatar, Kuwait).
• Globally Recognized Quality: GCP/GLP/GMP-driven operations ensure credible, defensible BE data.
• Advanced BE Capabilities: Support for MR formulations, HVDs, ophthalmics, inhalation, injectables, topicals & complex generics.
• Ideal for GCC Market Entry: BE datasets prepared are acceptable across Gulf regulatory networks.
• Complete End-to-End Services: From feasibility assessment to full CTD dossier finalization.

🗺️ BA/BE Study Workflow for Bahrain

1. Feasibility & Regulatory Assessment
   (Reference product comparison, NHRA/GCC guideline mapping, biowaiver evaluation)

2. Protocol Development & Ethics Compliance
   (ICH-GCP–aligned protocol + international ethics approval)

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

4. Clinical Study Execution
   (Volunteer recruitment, dosing, sampling, safety monitoring)

5. Bioanalysis & PK/BE Statistical Evaluation
   (NCA, BE analysis, scaled BE when required)

6. NHRA-Ready CTD Documentation
   (CSR, CDP, validation package & Modules 1–5)

Who We Support in Bahrain & GCC Region

• GCC-based and international generic manufacturers
• Companies submitting via NHRA or GCC-DR centralized registration
• Contract research organizations outsourcing BA/BE or analytical phases
• R&D groups reformulating medicines for the Gulf market
• Export-oriented manufacturers targeting the Middle East
• Specialty pharma & biotech developers