🇦🇲 Bioavailability & Bioequivalence (BA/BE) Studies Services for Armenia
SCDMTE / MoH Armenia & EAEU-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to Armenia’s regulatory framework under:
Ministry of Health of the Republic of Armenia
Scientific Center of Drug and Medical Technology Expertise (SCDMTE)
Eurasian Economic Union (EAEU) unified pharmaceutical regulations
All studies strictly follow EAEU BE guidelines, MoH Armenia regulations, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for Armenia and regional EAEU submissions.
💊 Core Services for Armenia (SCDMTE / EAEU) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: EAEU-accepted single-dose & multiple-dose BE studies (crossover & parallel).
• Volunteer Selection: Healthy volunteers or patient cohorts depending on therapeutic requirements.
• Ethics Approval: Required approval from an accredited Armenian Ethics Committee/IRB.
• Protocol Development: Designed according to EAEU BE guidelines, ICH E6 (R2) GCP, and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for generic submissions, formulation changes, and equivalence demonstration.
• Dissolution Media: Pharmacopeial and biorelevant media recognized by EAEU & Armenia.
• Similarity Factor: f2 similarity factor for dissolution profile comparison.
• Evaluation Approaches: Includes model-independent (f1, f2) and model-dependent dissolution models.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared per WHO TRS, ICH Q6A, and EAEU biowaiver criteria.
• IVIVC Modeling: Level A, B, and C IVIVC models.
• Predictive PK Modeling: Supports regulatory justification for biowaiver submissions.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV analytical systems.
• Validation: Per ICH M10, WHO TRS, and EAEU/Eurasian analytical validation requirements.
• Stability-Indicating Methods: Developed for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA).
• BE Statistics: Conducted according to EAEU, ICH, and WHO harmonized statistical criteria.
• Sample Size & Power: Determined scientifically for reliable BE study outcomes.
📑 Armenia SCDMTE / EAEU–Ready Regulatory Documentation
We prepare complete documentation for Armenia and EAEU submissions, including:
• Clinical Study Protocol (Armenia/EAEU-compliant)
• Informed Consent Forms (ICF) meeting Armenian ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) per EAEU + ICH structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• EAEU CTD Modules (1–5) formatted for SCDMTE submission
✨ Why Choose BioEquiGlobal for the Armenian & EAEU Market?
• Regulatory Expertise: BA/BE studies, dissolution profiling, PK analysis, and CTD dossier preparation aligned with SCDMTE and EAEU standards.
• International Quality Compliance: All processes follow GCP, GLP, WHO TRS, and ICH under a robust QA system.
• Advanced Facilities: Equipped with accredited clinical units and high-performance analytical laboratories (including NABL-certified labs).
• Global Submission Capability: CTDs prepared for EAEU, Armenia, and global authorities (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Armenia
Feasibility & Gap Assessment: Evaluation of reference products, dissolution compatibility, and biowaiver potential.
Protocol Development: Drafting Armenia/EAEU-compliant BE protocols and securing Ethics Committee approval.
Analytical Method Development: LC-MS/MS method development & validation per ICH M10 & WHO TRS.
Clinical Execution: GCP-supervised volunteer recruitment, dosing, PK sampling, and safety assessment.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and EAEU-standard BE statistics.
Documentation & Submission: Preparation of SCDMTE/EAEU-ready CSR, dissolution reports, validation packages, and CTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Armenia & EAEU markets
• CROs requiring BE study outsourcing or analytical support
• Regulatory teams needing EAEU-compliant CTD dossiers