🇺🇦 Bioavailability & Bioequivalence (BA/BE) Studies Services for Ukraine

SEC / Ministry of Health–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 tailored to the regulatory framework of Ukraine’s:

• State Expert Center (SEC) of the Ministry of Health

• Ministry of Health of Ukraine (MoH Ukraine)

All studies strictly follow SEC guidelines, EU-EMA principles, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for Ukrainian registration and international submissions.

💊 Core Services for Ukraine (SEC / MoH) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose BA/BE studies in crossover or parallel designs recognized by SEC and EMA.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic requirements.
• Ethics Approval: Approval from a Ukrainian Research Ethics Committee (REC)/IRB as required by national law.
• Protocol Development: Prepared per ICH E6 (R2) GCP, EU/EMA guidelines, WHO TRS, and SEC methodological requirements.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Required for generic product registration, formulation changes, and equivalence evaluation.
• Dissolution Media: Pharmacopeial & biorelevant media accepted by SEC and EU authorities.
• Similarity Factor: f2 similarity factor for comparing dissolution curves.
• Evaluation Approaches: Model-independent (f1, f2) and EMA-recognized model-dependent methods.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to WHO TRS, EMA/ICH guidance, and SEC’s regulatory expectations.
• IVIVC Modeling: Level A, B, and C correlation models for improved predictability.
• Predictive PK Modeling: Supports biowaiver justification and optimized regulatory strategies.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV bioanalytical systems.
• Validation: Per ICH M10, WHO TRS, and Ukraine SEC-recognized validation requirements.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.

Pharmacokinetic (PK) Analysis

• PK Method: Non-compartmental analysis (NCA).
• BE Statistics: Conducted using ICH/EMA harmonized methods accepted by SEC.
• Sample Size & Power: Statistically justified for conclusive BE outcomes.

📑 Ukraine SEC–Ready Regulatory Documentation

We prepare complete Ukraine-specific regulatory documents, including:

• Clinical Study Protocol (Ukraine/EU-compliant)
• Informed Consent Forms (ICF) per Ukrainian ethical norms
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & EMA/SEC structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• EU CTD Modules (1–5) formatted for SEC submission

✨ Why Choose BioEquiGlobal for the Ukrainian Market?

• Local Regulatory Expertise: Deep knowledge of SEC guidelines and Ukraine’s EMA-aligned regulatory framework.
• Global Quality Systems: Full compliance with GCP, GLP, WHO TRS, and ICH standards with robust QA oversight.
• Advanced Facilities: Accredited clinical research units and modern analytical laboratories (including NABL-certified facilities).
• Worldwide Submission Capability: CTD dossiers prepared for Ukraine and global agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Ukraine

1. Feasibility & Gap Assessment: Review of reference product availability, dissolution requirements, and biowaiver eligibility.

2. Protocol Development: Drafting SEC-compliant BA/BE protocols and coordinating REC/IRB approval.

3. Analytical Method Development: LC-MS/MS method design & validation per ICH M10 & WHO TRS.

4. Clinical Study Execution: GCP-monitored recruitment, dosing, blood sampling, and safety monitoring.

5. Bioanalysis & PK Evaluation: PK modeling, QC verification, and complete BE statistical analysis.

6. Documentation & Submission: Preparation of SEC-ready CSR, CDP report, validation documentation, and CTD Modules 1–5.

Who We Support

• Ukrainian pharmaceutical manufacturers seeking SEC approval
• CROs requiring BA/BE outsourcing or analytical support
• Regulatory teams needing SEC-compliant CTD dossiers