🇧🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Belgium
FAMHP & EMA-Compliant BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling, aligned with Belgium’s regulatory requirements under the FAMHP (Federal Agency for Medicines and Health Products) and the broader European Medicines Agency (EMA) framework.
Our studies strictly follow:
FAMHP Regulations for Clinical Trials & BE 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, GLP & GMP Standards
European Pharmacopoeia (Ph. Eur.)
Belgium is known globally as a top-tier location for clinical research, offering fast ethics approvals, highly experienced investigators, and some of Europe’s most efficient trial initiation timelines.
💊 Core BA/BE Services for Belgium & EMA Submissions
Clinical BA/BE Studies (Human)
• Conducted in full compliance with FAMHP, EMA & EU-GCP.
• Single-dose and multiple-dose BE studies (crossover or parallel).
• Healthy volunteer studies or patient-based PK studies as required.
• Approval through Belgian Ethics Committees + FAMHP validation, in line with EU-CTR.
• Protocols developed according to ICH E6 (R2) and EMA BE guidance.
Comparative Dissolution Profiling (CDP)
• Required for EU generic applications (Article 10).
• Dissolution testing per Ph. Eur., USP, and biorelevant media.
• Similarity factor (f2) analysis for release profile comparisons.
• Model-dependent & model-independent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-based biowaiver justification per EMA & ICH Q6A.
• Level A/B/C IVIVC modeling to correlate in vitro dissolution with in vivo PK.
• Suitable for BCS Class I & III biowaivers under EU guidance.
Analytical Method Development & Validation
• Bioanalytical method development using LC-MS/MS & HPLC-UV.
• Validation per ICH M10, accepted by FAMHP & EMA.
• Stability-indicating methods for APIs & finished drug products.
• Full validation: accuracy, precision, linearity, selectivity & stability.
Pharmacokinetic (PK) & BE Statistical Evaluation
• Non-compartmental PK analysis of AUC, Cmax, Tmax, t½.
• EMA-standard BE range: 90% CI within 80.00–125.00%.
• Scaled average BE for Highly Variable Drugs (HVDs).
• Power and sample-size calculations aligned with EMA statistical guidance.
📑 Belgium- & EMA-Ready CTD Documentation
We prepare submission-ready documentation for Belgium and all EU procedures:
• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) compliant with ICH E3 & EMA structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile (CDP) Report
• CTD Modules 1–5 for:
EU Generic Applications (Article 10)
Decentralized Procedure (DCP)
Mutual Recognition Procedure (MRP)
Centralized Procedure (CP)
✨ Why Choose BioEquiGlobal for Belgium?
• World-Class Clinical Research Hub: Belgium offers some of the fastest ethics & regulatory review timelines in the EU.
• EMA-Aligned BE Expertise: Ensures BE data generated are valid for EU-wide submissions.
• Strong Quality Standards: GCP-, GLP-, and GMP-driven operations ensure compliance with FAMHP & international authorities.
• Ideal for EU Market Entry: Belgium is frequently chosen by global pharma for its advanced research infrastructure.
• End-to-End BE Solutions: From feasibility and protocol writing to PK/BE statistics and full CTD dossier preparation.
🗺️ BA/BE Study Workflow for Belgium / EU Sponsors
Feasibility Assessment & EMA Guideline Mapping
(Reference product, BE pathway, biowaiver feasibility)Protocol Development & Ethics Committee Review
(Submission to Belgian Ethics Committees under EU-CTR)Analytical Method Development & Validation
(ICH M10-compliant validation & method optimization)Clinical Study Execution in Belgium
(Recruitment, dosing, PK sampling & GCP oversight)Bioanalysis & PK/BE Interpretation
(NCA + statistical BE evaluation, including scaled BE)CTD Documentation Preparation
(CSR, CDP, validation package & Modules 1–5)
Who We Support in Belgium & Across Europe
• Generic pharmaceutical manufacturers
• EU MAH applicants using DCP, MRP & CP
• CROs outsourcing BA/BE or analytical phases
• R&D units reformulating existing EU-authorized medicines
• Export-driven pharma entering the EU
• Biotech & specialty pharma companies