🇵🇱 Bioavailability & Bioequivalence (BA/BE) Studies Services for Poland
URPL & EMA-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA) and Bioequivalence (BE) studies, along with Comparative Dissolution Profiling, specifically tailored for pharmaceutical companies conducting clinical research in Poland or preparing submissions for the European Union (EU) market.
All services are fully compliant with:
URPL (Urząd Rejestracji Produktów Leczniczych) requirements
EMA Guideline on the Investigation of Bioequivalence (2010/2022 Update)
EU Clinical Trial Regulation (CTR 536/2014)
ICH Guidelines (E6 R2, Q2, Q6A, M10)
EU-GCP, EU-GLP & EU-GMP (Annex 13)
European Pharmacopoeia (Ph. Eur.)
Poland is one of Europe’s fastest-growing clinical trial hubs, offering strong infrastructure, highly qualified investigators, and efficient Ethics Committee processes — making it ideal for BA/BE studies.
💊 Core BA/BE Services for Poland & EMA Submissions
Clinical BA/BE Studies (Human)
• Conducted according to URPL, EMA BE Guidelines, and EU-GCP standards.
• Single-dose & multiple-dose BE studies with crossover or parallel design.
• Healthy volunteer studies or patient-based PK/BE studies where required.
• Ethical approval obtained through Polish Bioethics Committees, compliant with EU-CTR 536/2014.
• Protocols aligned with EMA BE guidance, ICH E6 (R2), and Ph. Eur. criteria.
Comparative Dissolution Profiling (CDP)
• Required for EU generics submitted under Directive 2001/83/EC (Article 10).
• Dissolution studies conducted using Ph. Eur., USP, EP, and biorelevant media.
• Similarity factor (f2) calculations for dissolution equivalence.
• Model-independent & model-dependent dissolution evaluation.
IVIVC & Biowaiver Support
• BCS-based biowaiver aligned with EMA Biowaiver Guidance and ICH Q6A.
• Level A/B/C IVIVC modeling for product predictability.
• Waiver support for BCS Class I & III drugs under EU rules.
Analytical Method Development & Validation
• LC-MS/MS & HPLC-UV method development and full validation.
• Conducted per ICH M10 — fully accepted in Poland & the EU.
• Stability-indicating analytical methods for APIs and formulations.
• Validation includes accuracy, precision, selectivity, sensitivity & stability.
Pharmacokinetic (PK) & Statistical BE Analysis
• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• BE acceptance limits 80.00–125.00% (90% CI) per EMA requirements.
• Scaled BE for Highly Variable Drugs (HVDs) when applicable.
• Study power & sample-size calculation per EMA expectations.
📑 URPL- & EMA-Ready CTD Documentation
We prepare complete regulatory documentation for Polish and EU submissions:
• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per ICH E3 & EMA template
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• EU CTD Modules 1–5 for:
Generic Applications (Article 10)
Decentralized Procedure (DCP)
Mutual Recognition Procedure (MRP)
Centralized Procedure (CP)
✨ Why Choose BioEquiGlobal for Poland?
• Strategic EU Clinical Trial Location: Poland is a preferred destination for BE studies due to high-quality clinical infrastructure and competitive timelines.
• EMA-Aligned Methodology: BE protocols & documentation fully match EMA requirements for Europe-wide submissions.
• Regulatory Precision: URPL expectations and EU-CTR obligations are integrated into every study design.
• High Compliance Standards: GCP-, GLP- & GMP-driven systems ensure global data acceptability.
• End-to-End Support: From feasibility & BE strategy to PK/BE evaluation and CTD dossier preparation.
🗺️ BA/BE Study Workflow for Poland / EU Sponsors
Feasibility & EMA/URPL Gap Assessment
(Reference selection, guideline mapping, biowaiver evaluation)Protocol Development & Ethics Approval
(Submission to Polish Bioethics Committees under EU-CTR)Analytical Method Development & Validation
(ICH M10-compliant LC-MS/MS validation)Clinical Study Execution in Poland
(Volunteer recruitment, dosing, PK sampling & safety monitoring)Bioanalysis & PK/BE Interpretation
(NCA, BE statistics, scaled BE for HVDs)Final Documentation & CTD Submission
(CSR, CDP, analytical validation & CTD Modules 1–5)
Who We Support in Poland & the EU
• Generic pharmaceutical manufacturers
• EU Marketing Authorization Holders (MAHs)
• CROs requiring PK/bioanalytical outsourcing
• Pharmaceutical R&D centers reformulating existing EU products
• Export-focused pharmaceutical companies entering EU markets
• Biotech & specialty pharma companies