🇦🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for the United Arab Emirates

MOHAP & GCC-DR Compliant BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA) and Bioequivalence (BE) studies, along with Comparative Dissolution Profiling, fully adapted to the regulatory expectations of the United Arab Emirates (UAE) under:

• MOHAP – UAE Ministry of Health & Prevention

• GCC Central Committee for Drug Registration (GCC-DR)

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

• WHO TRS & internationally harmonized BE guidelines

• GCP, GLP & GMP requirements

• USP / Ph. Eur. dissolution standards

The UAE is a rapidly growing pharmaceutical market with strong regulatory oversight and high demand for quality BA/BE data for both local and GCC-wide registrations.

💊 Core BA/BE Services for UAE (MOHAP/GCC)

Clinical BA/BE Studies (Human)

• Designed according to MOHAP BE guidance & accepted GCC BE principles.
• Single-dose & multiple-dose BE study designs (crossover or parallel).
• Healthy volunteer studies or patient-specific PK studies where needed.
• Ethical approval via accredited UAE-based Ethics Committees (IRBs).
• Protocols follow ICH E6 (R2), MOHAP requirements & GCC regulatory expectations.

Comparative Dissolution Profiling (CDP)

• Required for MOHAP Generic, Branded Generic & GCC submissions.
• Dissolution testing using USP / Ph. Eur. and biorelevant media.
• Calculation of similarity factor (f2) for dissolution equivalence.
• Model-independent & model-dependent dissolution comparisons.

IVIVC & Biowaiver Support

• BCS-based biowaiver preparation aligned with GCC guidelines, ICH Q6A, WHO TRS.
• Level A/B/C IVIVC modeling for dissolution–PK correlation.
• Biowaiver eligibility for BCS Class I & III APIs when justified.

Analytical Method Development & Validation

• Bioanalytical assays built on LC-MS/MS & HPLC-UV systems.
• Validation carried out per ICH M10, recognized by MOHAP & GCC.
• Stability-indicating method development for APIs & finished products.
• Full validation: precision, accuracy, linearity, selectivity & stability.

Pharmacokinetic (PK) & BE Statistical Evaluation

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• Standard BE acceptance limits: 80–125% (90% CI).
• Handling of highly variable drugs (HVDs) through accepted scaling approaches.
• Sample-size and statistical power calculations per GCC-recommended standards.

📑 MOHAP- & GCC-Ready Regulatory Documentation

We prepare complete BA/BE dossier components for UAE & GCC submissions:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) compliant with ICH E3 & MOHAP structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/eCTD Modules 1–5 for:

• UAE National Registration (MOHAP)

• GCC Central Registration (GCC-DR)

• Variations requiring BE support

✨ Why Choose BioEquiGlobal for the UAE?

• MOHAP- & GCC-Focused Compliance: Every BE study is designed to meet UAE-specific expectations and GCC harmonized standards.
• Global-Standard Quality: GCP-, GLP-, and GMP-driven operations ensure worldwide acceptability of BE data.
• Specialization in Complex Formulations: Including MR, HVDs, ophthalmics, inhalation products, topicals & injectables.
• Supports UAE + GCC Markets: A single BE study package can often support submissions to KSA, Oman, Bahrain, Kuwait, Qatar & UAE.
• End-to-End BE Capability: From feasibility to PK/BE statistics and complete CTD dossier preparation.

🗺️ BA/BE Study Workflow for UAE/GCC Sponsors

1. Feasibility Review & GCC Regulatory Mapping
   (Reference product assessment, BE strategy, biowaiver feasibility)

2. Protocol Development & IRB Approval
   (Compliance with UAE MOHAP & ICH E6 R2)

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

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

5. Bioanalysis & PK/BE Interpretation
   (NCA, statistical BE evaluation, HVD scaling as applicable)

6. MOHAP/GCC Submission Documentation
   (CSR, CDP, method validation reports & CTD Modules)

Who We Support in the UAE & GCC Region

• UAE-based pharmaceutical manufacturers
• GCC-wide MAH applicants (KSA, Kuwait, Qatar, Bahrain, Oman, UAE)
• CROs outsourcing PK, bioanalytical or BE work
• Innovators & generic pharmaceutical companies
• Global pharma entering the Middle Eastern market
• R&D & export-driven pharmaceutical organizations