🇮🇶 Bioavailability & Bioequivalence (BA/BE) Studies Services for Iraq
Iraq MOH–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for the regulatory requirements of the Iraq Ministry of Health (MOH) and the Drug Registration & Pharmaceutical Licensing Directorate.
All studies follow GCP, GLP, WHO TRS, ICH guidelines, and Iraq’s technical requirements for pharmaceutical product registration, ensuring suitability for both domestic approvals and international submissions.
💊 Core Services for Iraq MOH Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs as accepted by the Iraq MOH.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on therapeutic class and MOH guidance.
• Ethics Approval: Approval from a recognized Institutional Ethics Committee (IEC/IRB) under Iraq’s healthcare regulatory framework.
• Protocol Compliance: BA/BE protocols developed in accordance with ICH E6 (R2) GCP, WHO TRS, and Iraq MOH registration guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration and post-approval changes per MOH and WHO TRS standards.
• Dissolution Media: Pharmacopeial and biorelevant media suitable for Iraq registration.
• Similarity Assessment: f2 similarity factor for test vs. reference product comparison.
• Analytical Approaches: Model-independent (f1, f2) and model-dependent dissolution comparisons.
IVIVC & Biowaiver Support
• BCS Biowaiver Documentation: Developed according to WHO TRS, ICH Q6A, and MOH-accepted scientific standards.
• IVIVC Modeling: Level A, B, and C predictive models to justify in vitro–in vivo correlation.
• Predictive Dissolution–PK Analysis: Supports product development and regulatory acceptance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems for drug quantification.
• Validation Standards: Conducted as per ICH M10, WHO guidelines, and Iraq MOH-accepted validation criteria.
• Stability Studies: Stability-indicating method development for drug substances and drug products.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA) used for all BA/BE assessments.
• Statistical BE Evaluation: Based on ICH, WHO, and internationally harmonized statistical requirements recognized by the Iraq MOH.
• Sample-Size & Power Calculation: Performed to ensure conclusive BE outcomes for regulatory submissions.
📑 Iraq MOH–Ready Regulatory Documentation
We prepare full documentation required by the Drug Registration & Pharmaceutical Licensing Directorate, MOH Iraq, including:
• Clinical Study Protocol (aligned with Iraq MOH expectations)
• Informed Consent Forms (ICF) reflecting local ethical and cultural considerations
• Investigator Brochure
• Clinical Study Report (CSR) per ICH and WHO formats
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD modules for Iraq MOH pharmaceutical product registration
✨ Why Choose BioEquiGlobal for the Iraqi Market?
• Iraq-Focused BA/BE Expertise: Protocols, dissolution assessments, and analytical reports adapted to MOH guidelines.
• Quality Systems: Full compliance with GCP, GLP, and internationally harmonized standards.
• Advanced Laboratory Infrastructure: Accredited clinical units and high-quality analytical labs (including NABL-certified labs where applicable).
• Global-Standard Dossiers: Preparation of submission-ready CTD/ACTD files for Iraq, as well as US FDA, EMA, GCC, SFDA, MHRA, TGA, and others.
🗺️ BA/BE Study Workflow for Iraq
Feasibility & Gap Assessment: Evaluation of reference products available in Iraq, BCS classification, and biowaiver eligibility.
Protocol Development: Drafting Iraq MOH–aligned BA/BE protocols and facilitating ethics committee approval.
Analytical Method Development: LC-MS/MS method development and validation adhering to ICH M10 and WHO TRS.
Clinical Phase Execution: GCP-compliant dosing, sample collection, monitoring, and safety oversight.
PK & BE Analysis: Bioanalysis, PK modeling, QC verification, and statistical BE comparison.
Documentation & Submission: Preparation of CSR, dissolution profile reports, analytical validations, and CTD/ACTD modules for MOH submission.
Who We Support
• Iraqi pharmaceutical companies seeking MOH product registration
• Regional CROs requiring BA/BE, analytical, or documentation support
• International companies seeking Iraq MOH–compliant CTD/ACTD dossiers