🇬🇷 Bioavailability & Bioequivalence (BA/BE) Studies Services for Greece
EOF & 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 tailored for pharmaceutical submissions to Greece’s EOF (National Organization for Medicines).
Our services comply with:
EOF Requirements for Clinical Trials & Bioequivalence Studies
EMA Guideline on the Investigation of Bioequivalence (2010/2022 update)
EU Clinical Trial Regulation (EU-CTR 536/2014)
ICH Guidelines (E6 R2, Q2, Q6A, M10)
EU-GCP, EU-GLP & EU-GMP (Annex 13)
European Pharmacopoeia (Ph. Eur.)
Greece is one of Europe’s most active regions for clinical research, known for experienced investigators, reliable patient recruitment, and rapid regulatory coordination under EU-CTR.
💊 Core BA/BE Services for Greece & EMA Submissions
Clinical BA/BE Studies (Human)
• Conducted in accordance with EOF, EMA and EU-GCP standards.
• Single-dose and multiple-dose BE studies (crossover or parallel).
• Healthy volunteer studies or patient studies depending on therapeutic area.
• Ethical approval via Greek National Bioethics Committees under EU-CTR.
• Protocol development aligned with ICH E6 (R2) and EMA BE guidelines.
Comparative Dissolution Profiling (CDP)
• Required for EU generic applications (Article 10).
• Dissolution studies performed using Ph. Eur., USP, and biorelevant media.
• Assessment of dissolution similarity using f2 similarity factor.
• Model-independent and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• EMA-aligned BCS-based biowaiver justification per ICH Q6A.
• Level A/B/C IVIVC modeling for predictive PK–dissolution relationships.
• Applicable for BCS Class I & III compounds.
Analytical Method Development & Validation
• LC-MS/MS & HPLC-UV analytical method development.
• Validation per ICH M10, accepted by EOF & EMA.
• Stability-indicating assay development for APIs and finished products.
• Precision, accuracy, linearity, specificity & stability assessments.
Pharmacokinetic (PK) & BE Statistical Analysis
• Non-compartmental PK calculations (AUC, Cmax, Tmax, t½).
• EMA-defined BE acceptance limits: 90% CI within 80–125%.
• Scaled BE methodology for Highly Variable Drugs (HVDs).
• Power & sample-size estimations following EU regulatory expectations.
📑 EOF- & EMA-Ready CTD Documentation
We prepare complete CTD packages suitable for Greece and all EU submissions:
• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per ICH E3 & EMA structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 1–5, for:
Generic applications (Article 10)
DCP (Decentralized Procedure)
MRP (Mutual Recognition Procedure)
CP (Centralized Procedure)
✨ Why Choose BioEquiGlobal for Greece?
• Strong Clinical Trial Ecosystem: Greece has excellent clinical infrastructure and experienced trial centers.
• EOF + EMA Compliance: Ensures BE studies meet regulatory expectations across Greece and EU-wide.
• High Data Quality Standards: GCP/GLP/GMP-compliant systems guarantee global regulatory acceptance.
• Expertise in Complex Generics: Modified-release (MR), HVDs, topicals, ophthalmic, inhalation & parenterals.
• Full-Service BE Partner: From feasibility assessment to PK/BE analysis and complete CTD dossier development.
🗺️ BA/BE Study Workflow for Greece / EU Sponsors
Feasibility & EMA/EOF Regulatory Mapping
(Reference selection, biowaiver feasibility, BE strategy)Protocol Development & Ethics Approval
(Submission to Greek Ethics Committees under EU-CTR)Analytical Method Development & Validation
(ICH M10-compliant LC-MS/MS validation)Clinical Study Execution in Greece
(Recruitment, dosing, sampling under EU-GCP)Bioanalysis & PK/BE Interpretation
(NCA, BE statistics, scaled BE for HVDs)CTD Documentation Preparation
(CSR, CDP, validation package & Modules 1–5)
Who We Support in Greece & Across Europe
• Generic pharmaceutical manufacturers
• MAH holders applying via DCP, MRP & CP routes
• CROs seeking analytical or PK/BE outsourcing
• International pharmaceutical companies entering the Greek/EU markets
• Biotech & specialty pharma organizations