🇸🇾 Bioavailability & Bioequivalence (BA/BE) Studies Services for Syria
Ministry of Health (DDA Syria)–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 to the regulatory requirements of the Syrian Ministry of Health, specifically its Directorate of Drug Affairs (DDA).
All studies strictly comply with ICH, WHO TRS, GLP, GCP, and the quality and documentation requirements of Syria’s pharmaceutical registration system.
💊 Core Services for Syria (DDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel models accepted by DDA Syria.
• Volunteer Selection: Healthy volunteers or patient studies depending on therapeutic category.
• Ethics Approval: Approval required from a recognized Institutional Review Board (IRB)/Ethics Committee within Syria or internationally accredited boards.
• Protocol Development: BA/BE protocols aligned with ICH E6 (R2) GCP, WHO TRS, and Syrian regulatory expectations.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic product registration, variations, and equivalence demonstration per DDA guidelines.
• Media: Pharmacopeial and biorelevant dissolution media suitable for Syrian submissions.
• Similarity Factor: Calculation of f2 similarity factor for comparing dissolution curves.
• Evaluation Models: Model-independent (f1, f2) and model-dependent comparative methods.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and scientific principles accepted by Syrian regulators.
• IVIVC Models: Level A, B, and C predictive modeling.
• Predictive Dissolution–PK Correlation: Used to justify in vitro–in vivo equivalence.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems for precise quantification.
• Validation: Conducted per ICH M10, WHO TRS, and internationally accepted validation standards suitable for DDA submissions.
• Stability-Indicating Methods: Developed for APIs and finished dosage forms.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Performed according to ICH/WHO harmonized BE testing principles.
• Study Powering: Sample-size and power calculations compliant with regulatory expectations.
📑 Syria MOH–Ready Regulatory Documentation
We prepare complete documentation required by the Directorate of Drug Affairs (DDA), Ministry of Health Syria, including:
• Clinical Study Protocol (Syria-aligned)
• Informed Consent Forms (ICF) meeting local ethical guidelines
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS formats
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for Syria drug registration requirements
✨ Why Choose BioEquiGlobal for the Syrian Market?
• Syria-Focused Regulatory Compliance: BA/BE study design, PK analysis, dissolution profiles, and dossier preparation aligned with Syrian MOH requirements.
• Global Quality Alignment: Compliance with GCP, GLP, WHO TRS, and ICH standards supported by strong internal QA systems.
• High-Performance Infrastructure: Accredited clinical units and precision analytical laboratories (including NABL-certified labs where applicable).
• International Dossier Support: CTD/ACTD submissions prepared for Syria and international authorities including US FDA, EMA, MHRA, GCC, TGA, and African agencies.
🗺️ BA/BE Study Workflow for Syria
Feasibility & Gap Assessment: Review of Syrian reference products, biowaiver eligibility, and dissolution method suitability.
Protocol Development: Drafting a Syria MOH–compliant BA/BE protocol and facilitating needed ethical approvals.
Analytical Method Development: Validation of LC-MS/MS analytical methods per ICH M10 and WHO TRS.
Clinical Study Execution: GCP-monitored volunteer recruitment, dosing, sampling, and safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical comparison.
Documentation & Submission: Preparation of Syria MOH–ready CSR, dissolution report, validation documents, and CTD/ACTD modules.
Who We Support
• Syrian pharmaceutical manufacturers seeking MOH drug registration
• CROs requiring BA/BE outsourcing or analytical support
• International companies needing Syria MOH–compliant CTD/ACTD dossiers