🇦🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for UAE
MOHAP/GCC-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., provides comprehensive Bioavailability/Bioequivalence (BA/BE) study services and Comparative Dissolution Profiling (CDP) tailored to the UAE Ministry of Health & Prevention (MOHAP), GCC Drug Regulatory Authority, and UAE healthcare authorities (DOH Abu Dhabi, DHA Dubai).
All studies are conducted in accordance with GCC guidelines, MOHAP requirements, ICH, WHO TRS, GCP, and GLP standards.
💊 Our Core Services for UAE (MOHAP/GCC) Regulatory Submissions
Clinical BA/BE Studies (Human)
Study Designs: Single-dose & multiple-dose, crossover & parallel designs as required by MOHAP & GCC guidelines.
Volunteer/Patient Studies: Conducted in accordance with UAE clinical research standards and GCP compliance.
Ethics Approval: IRB/Ethics Committee approval from UAE-authorized Ethics Boards (MOHAP/DOH/DHA compliant).
Protocol Standards: Designed per GCC unified BA/BE guidelines, ICH E6 (R2), and UAE-specific safety/ethical requirements.
Comparative Dissolution Profiling (CDP)
Regulatory Requirement: Essential for generic drug submissions and post-approval variations under MOHAP and GCC frameworks.
Dissolution Media: Biorelevant & pharmacopoeial media as per GCC/ICH dissolution method expectations.
Comprehensive Analysis: f2 similarity factor, model-dependent & model-independent comparisons.
Regulatory Output: Full CDP report aligned to UAE MOHAP submission expectations.
IVIVC & Biowaiver Support
BCS-Based Biowaiver: Prepared according to GCC BA/BE & BCS guidelines, ICH Q6A, and WHO standards.
IVIVC Modeling: Level A, B, and C correlation models.
Predictive Evaluation: In vitro–in vivo correlation and PK predictions suitable for MOHAP assessment.
Analytical Method Development & Validation
Platforms: LC-MS/MS and HPLC-UV analytical techniques.
Validation Standards: As per ICH M10 and GCC-recommended bioanalytical validation practices.
Stability Studies: Stability-indicating method development for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) & Bioequivalence Statistics
PK Modeling: Non-compartmental analysis.
BE Statistical Analysis: ln-transformed CI, ANOVA models, and GCC-accepted BE evaluation methods.
Sample Size/Power: Estimated according to GCC and UAE submission requirements.
📑 UAE MOHAP/GCC-Ready Regulatory Documentation
We prepare complete documentation sets formatted for MOHAP, GCC Drug Regulatory Authorities, and UAE regional health bodies.
Includes:
Clinical Study Protocol
Informed Consent Forms (Arabic/English as applicable)
Investigator’s Brochure
Clinical Study Report (CSR) structured for MOHAP/GCC
Bioanalytical Method Validation Report
Comparative Dissolution Profile Report
CTD/ACTD Modules ready for GCC Unified Drug Registration
Additional MOHAP and DOH/DHA submission forms (if required)
✨ Why Choose BioEquiGlobal for the UAE Market?
Regulatory Expertise: Deep knowledge of MOHAP & GCC BA/BE expectations.
Quality Systems: GCP/GLP-driven operations, QA audits, and SOP-led workflows.
Global Clinical & Analytical Network: Access to validated labs and accredited clinical research units.
Multimarket Support: UAE + GCC + international dossier preparation (US FDA, EMA, MHRA, TGA, India).
🗺️ Our BA/BE Workflow for UAE
1. Feasibility & UAE/GCC Gap Assessment
Assessment of reference product requirements, submission expectations, and regulatory classification in the UAE.
2. Protocol Development & Ethics Approval
Preparation of MOHAP/GCC-compliant protocol and securing IRB approval through UAE-recognized bodies.
3. Analytical Method Development
ICH M10-based LC-MS/MS method development and validation.
4. Clinical Study Execution
Recruitment, dosing, sample handling, and monitoring under ICH-GCP guidelines.
5. Bioanalysis, PK & BE Evaluation
Bioanalysis, PK calculations, and GCC-standard BE statistical evaluation.
6. Documentation & Submission Support
CSR preparation, CDP reporting, and assembly of CTD modules for GCC/MOHAP submission.
Who We Support in UAE & GCC
UAE pharmaceutical manufacturers seeking MOHAP approval.
GCC-focused companies requiring harmonized BA/BE data packages.
CROs outsourcing analytical or clinical BA/BE activities.
Regulatory teams preparing GCC/CTD submissions.