🇰🇿 Bioavailability & Bioequivalence (BA/BE) Studies Services for Kazakhstan
EAEU & Kazakhstan MoH–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the requirements of Kazakhstan’s National Center for Expertise of Medicines and Medical Devices (NCEMMD) and EAEU regulatory standards.
All studies strictly follow Kazakhstan MoH regulations, EAEU BE guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for national and regional (EAEU) pharmaceutical submissions.
💊 Core Services for Kazakhstan (MoH / NCEMMD / EAEU) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BA/BE studies using crossover or parallel models accepted by EAEU and Kazakhstan MoH.
• Volunteer Selection: Healthy volunteers or patient groups, depending on therapeutic class.
• Ethics Approval: Required through a Kazakhstan-recognized Local Ethics Committee (LEC).
• Protocol Development: Fully aligned with EAEU, Kazakhstan MoH, ICH E6 (R2) GCP, and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Needed for generic submissions and formulation modifications under Kazakhstan MoH and EAEU standards.
• Dissolution Media: Pharmacopeial and biorelevant media recognized by EAEU.
• Similarity Factor: f2 similarity factor used for dissolution comparison.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent dissolution modeling as required by EAEU.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared per WHO TRS, ICH Q6A, and EAEU-specific biowaiver standards.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Supports biowaiver justification and BE assessment.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems.
• Validation: Conducted according to ICH M10, WHO TRS, and Kazakhstan/EAEU analytical standards.
• Stability-Indicating Methods: Developed for APIs and pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• BE Statistics: Performed using ICH and EAEU harmonized approaches accepted by Kazakhstan authorities.
• Sample Size & Power: Scientifically determined to ensure BE conclusion reliability.
📑 Kazakhstan MoH / NCEMMD / EAEU–Ready Regulatory Documentation
We prepare comprehensive regulatory documentation suitable for submission to Kazakhstan’s Ministry of Health and NCEMMD, including:
• Clinical Study Protocol (Kazakhstan/EAEU-compliant)
• Informed Consent Forms (ICF) meeting ethical norms
• Investigator Brochure
• Clinical Study Report (CSR) per EAEU + ICH standards
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• EAEU CTD Modules (1–5) formatted for Kazakhstan MoH submissions
✨ Why Choose BioEquiGlobal for the Kazakhstan & EAEU Market?
• Kazakhstan/EAEU Regulatory Expertise: BE protocols, analytical validations, PK reports, and CTD dossiers aligned with Kazakhstan MoH and EAEU unified rules.
• International Quality Compliance: Strict adherence to GCP, GLP, WHO TRS, and ICH guidelines under strong QA oversight.
• Modern Infrastructure: Accredited clinical units and advanced analytical laboratories (including NABL-certified facilities).
• Global Submission Capability: CTD/ACTD dossiers for Kazakhstan, EAEU markets, and global regulators (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Kazakhstan
Feasibility & Gap Assessment: Review of EAEU-recognized reference products, dissolution expectations, and biowaiver feasibility.
Protocol Development: Drafting Kazakhstan/EAEU–compliant BA/BE protocols and securing Ethics Committee approval.
Analytical Method Development: LC-MS/MS validation per ICH M10 & EAEU/WHO guidelines.
Clinical Study Execution: GCP-supervised volunteer recruitment, dosing, sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and EAEU-standard BE evaluation.
Documentation & Submission: Preparation of Kazakhstan MoH/EAEU-ready CSR, dissolution data, validation reports, and CTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Kazakhstan or the EAEU market
• CROs requiring analytical or clinical outsourcing
• Regulatory teams needing Kazakhstan/EAEU-compliant CTD dossiers