🇷🇺 Bioavailability & Bioequivalence (BA/BE) Studies Services for Russia
MoH Russia, Roszdravnadzor & EAEU-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides end-to-end Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory standards of:
Ministry of Health of the Russian Federation (Минздрав России)
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP / ЦЭККМП)
Eurasian Economic Union (EAEU) BE Guidelines
All studies strictly follow EAEU rules, Russian MoH regulations, ICH standards, WHO TRS, GCP, and GLP.
💊 Core Services for Russia (MoH / Roszdravnadzor / EAEU) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BE studies using crossover or parallel models accepted by Russia & EAEU.
• Volunteer Selection: Healthy volunteers or patient-based studies as required by therapeutic category.
• Ethics Approval: Mandatory approval by an accredited Local Ethics Committee (LEC) in Russia.
• Protocol Development: Prepared according to EAEU BE Guidelines, GCP (ICH E6 R2), WHO TRS, and Russian MoH rules.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generics, post-approval variations, and formulation evaluations in Russia/EAEU.
• Dissolution Media: Pharmacopeial & biorelevant media aligned with EAEU and Russian standards.
• Similarity Factor: Calculation of the f2 similarity factor for dissolution profile comparison.
• Evaluation Approaches: Model-independent (f1, f2) and EMA/EAEU-recognized model-dependent methods.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared in accordance with WHO TRS, ICH Q6A, and EAEU biowaiver criteria.
• IVIVC Models: Level A, B, and C models for regulatory justification.
• Predictive PK Modeling: Supports biowaiver submission and BE optimization.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems suitable for Russian/EAEU BE requirements.
• Validation: Conducted per ICH M10, WHO TRS, and EAEU analytical validation rules.
• Stability-Indicating Methods: Developed for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Analysis: Non-compartmental analysis (NCA).
• BE Statistics: As per EAEU, ICH, and WHO harmonized methodologies recognized by MoH Russia.
• Sample Size & Power: Statistically determined for reliable BE outcomes.
📑 Russia MoH / Roszdravnadzor / EAEU–Ready Regulatory Documentation
We prepare full regulatory documentation for Russian and EAEU submissions, including:
• Clinical Study Protocol (Russia/EAEU-compliant)
• Informed Consent Forms (ICF) aligned with Russian ethical guidelines
• 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 submission through Russian regulatory channels
✨ Why Choose BioEquiGlobal for the Russian & EAEU Market?
• Russia/EAEU Regulatory Expertise: Deep familiarity with MoH Russia, Roszdravnadzor, and EAEU BE/CTD guidelines.
• Global Quality Standards: Compliance with GCP, GLP, WHO TRS, and ICH—supported by strict QA systems.
• Advanced Infrastructure: Accredited clinical facilities and state-of-the-art analytical laboratories (including NABL-certified facilities where applicable).
• Global Submission Capability: CTDs prepared for Russia, EAEU, and international regulators (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Russia
Feasibility & Gap Assessment: Review of EAEU reference products, dissolution requirements, and biowaiver eligibility.
Protocol Development: Preparation of Russia/EAEU-compliant BA/BE protocols and Ethics Committee submissions.
Analytical Method Development: LC-MS/MS development and validation per ICH M10 & EAEU rules.
Clinical Execution: GCP-supervised volunteer recruitment, dosing, blood sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC procedures, and EAEU-standard BE statistics.
Documentation & Submission: Finalization of Russia-ready CSR, CDP report, validation documentation, and CTD Modules 1–5.
Who We Support
• Pharmaceutical manufacturers targeting the Russian or EAEU markets
• CROs seeking analytical or clinical outsourcing
• Regulatory teams needing Russia/EAEU-compliant CTDs