🇭🇺 Bioavailability & Bioequivalence (BA/BE) Studies Services for Hungary
OGYÉI & EMA-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for pharmaceutical companies and CROs targeting approvals in Hungary and the wider European Union (EU).
All studies fully comply with:
OGYÉI (Hungarian National Institute of Pharmacy and Nutrition)
EMA Guideline on the Investigation of Bioequivalence (2010/2022)
EU Clinical Trial Regulation (CTR) 536/2014
ICH Guidelines (E6 R2, M10, Q2, Q6A)
EU-GCP, EU-GLP & EU-GMP (Annex 13)
European Pharmacopoeia (Ph. Eur.)
Hungary is recognized as one of Europe’s leading centres for high-quality clinical BA/BE studies, with strong infrastructure, experienced investigators, and an efficient regulatory environment under OGYÉI.
💊 Core BA/BE Services for Hungary & EMA Submissions
Clinical BA/BE Studies (Human)
• Conducted according to OGYÉI & EMA BE Guidelines.
• Single-dose & multiple-dose BE studies (crossover & parallel).
• Healthy volunteer & patient-based studies as per therapeutic area.
• Ethics Committee approval compliant with EU-CTR 536/2014.
• Protocols designed per EMA BE rules, ICH E6 (R2) & WHO TRS guidance.
Comparative Dissolution Profiling (CDP)
• Required for generics submitted under EU Directive 2001/83/EC (Article 10).
• Dissolution using Ph. Eur., USP & biorelevant media.
• Similarity factor (f2) calculation for EU dissolution equivalence.
• Model-independent & model-dependent dissolution kinetics evaluation.
IVIVC & Biowaiver Support
• BCS-based biowaiver justifications as per EMA Biowaiver Guideline & ICH Q6A.
• Level A/B/C IVIVC modeling supporting EU regulatory decisions.
• Applicable for BCS Class I & III under EU criteria.
Analytical Method Development & Validation
• LC-MS/MS & HPLC-UV platforms for bioanalysis.
• Method validation aligned with ICH M10, fully accepted in Hungary & EU.
• Stability-indicating methods for APIs & finished products.
• Complete validation for precision, accuracy, stability & linearity.
Pharmacokinetic (PK) & BE Statistical Analysis
• Non-compartmental PK analysis (AUC, Cmax, Tmax, etc.).
• BE acceptance range: 80.00–125.00% (90% CI) per EMA.
• Scaled average BE methodology for Highly Variable Drugs (HVDs).
• Power & sample-size calculations per EU guidelines.
📑 OGYÉI- & EMA-Ready CTD Documentation
We prepare full regulatory documentation including:
• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per EMA & ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• EU CTD Modules 1–5 for:
Generic submissions (Article 10)
Decentralized Procedure (DCP)
Mutual Recognition Procedure (MRP)
Centralized Procedure (CP)
✨ Why Choose BioEquiGlobal for Hungary?
• Hungary: A Leading EU BA/BE Hub
Renowned globally for experienced CROs, high volunteer availability & regulatory efficiency under OGYÉI.
• EMA-Centric Design
All studies follow EMA’s BE guideline updates & Ph. Eur. standards.
• High Quality & Compliance
GCP-, GLP-, and GMP-aligned processes ensure global acceptance.
• Support for Multimarket Submissions
One study supports registration across all EU/EEA member states.
• End-to-End Regulatory Strategy
From BE planning to CTD preparation, including DCP/MRP country selection support.
🗺️ BA/BE Study Workflow for Hungary-Based or EU-Focused Sponsors
Feasibility & EMA/OGYÉI Gap Assessment
(Reference products, biowaiver eligibility, BE strategy)Protocol Development & Ethics Approval
(Preparation & submission under EU-CTR)Analytical Method Development & Validation
(Per ICH M10 & Ph. Eur. standards)Clinical Study Execution in Hungary
(GCP-compliant dosing, sampling, safety monitoring)Bioanalysis & PK/BE Assessment
(NCA, statistical evaluation, scaled BE)Final CTD Documentation & Submission
(CSR, dissolution report, validation package & CTD Modules)
Who We Support in Hungary & EU
• Generic pharmaceutical manufacturers
• MAH holders submitting via DCP, MRP, or CP
• CROs outsourcing analytical or PK/BE services
• EU-based & global companies targeting European markets
• R&D centers reformulating existing EU products
• Export-oriented pharmaceutical manufacturers