🇫🇷 Bioavailability & Bioequivalence (BA/BE) Studies Services for France

ANSM & EMA-Compliant BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA) and Bioequivalence (BE) studies, along with Comparative Dissolution Profiling, customized for regulatory submissions in France under the ANSM and the European Medicines Agency (EMA) framework.

All study services strictly adhere to:

• ANSM Clinical Trial & BE Requirements

• 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.)

France is one of Europe’s most advanced pharmaceutical and clinical research markets, offering world-class research sites, strong ethics oversight, and strict regulatory compliance.

💊 Core BA/BE Services for France & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted in accordance with ANSM, EMA & EU-GCP guidelines.
• Single-dose and multiple-dose BE studies using crossover or parallel designs.
• Studies in healthy volunteers or relevant patient groups.
• Ethical approval via CPP – Comité de Protection des Personnes, under EU-CTR.
• Protocol development following ICH E6 (R2) and EMA BE guidance.

Comparative Dissolution Profiling (CDP)

• Required for EU generic (Article 10) submissions.
• Dissolution performed using Ph. Eur., USP, and biorelevant media.
• Similarity factor (f2) calculation for dissolution equivalence.
• Kinetic (model-dependent) & model-independent dissolution analysis.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification as per EMA & ICH Q6A.
• Level A/B/C IVIVC modeling for dissolution–PK predictability.
• Suitable for BCS Class I & III APIs under EU regulatory provisions.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV analytical method development and validation.
• Full validation per ICH M10, accepted by ANSM & EMA.
• Stability-indicating analytical methods for APIs & formulations.
• Validation includes precision, accuracy, linearity, specificity & stability.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• EMA-standard BE acceptance limits: 90% CI within 80.00–125.00%.
• Scaled average BE for Highly Variable Drugs (HVDs).
• Sample-size estimation and statistical power assessment per EMA guidelines.

📑 ANSM- & EMA-Ready CTD Documentation

We prepare full regulatory documentation for France and 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:

• EU Generic Applications (Article 10)

• Decentralized Procedure (DCP)

• Mutual Recognition Procedure (MRP)

• Centralized Procedure (CP)

✨ Why Choose BioEquiGlobal for France?

• Leading EU Clinical Research Environment: France offers highly experienced BE research centers & efficient ethics processes.
• EMA-Aligned Scientific Rigor: Ensures seamless acceptance across all EU/EEA states.
• Strong Oversight by ANSM: Guarantees compliance, safety & data integrity.
• Ideal for Complex Generic Development: Expertise in MR formulations, HVDs, topicals, inhalation, ophthalmic, parenterals, etc.
• End-to-End BE Study Execution: From feasibility assessment to PK/BE evaluation and final CTD dossier preparation.

🗺️ BA/BE Study Workflow for France / EU Sponsors

1. Feasibility & Regulatory Assessment
   (Reference product identification, EMA BE mapping & biowaiver evaluation)

2. Protocol Development & CPP Ethics Approval
   (EU-CTR compliant submission to French Ethics Committees)

3. Analytical Method Development & Validation
   (ICH M10-compliant LC-MS/MS or HPLC-UV validation)

4. Clinical Study Execution in France
   (Volunteer recruitment, dosing, PK sampling under GCP)

5. Bioanalysis & PK/BE Interpretation
   (NCA, BE statistics, scaled BE for HVDs)

6. CTD Documentation Preparation
   (CSR, CDP, validation reports & CTD Modules 1–5)

Who We Support in France & Across the EU

• EU generic manufacturers
• Marketing Authorization Holders (MAHs) applying via DCP, MRP & CP
• CROs seeking analytical or PK/BE outsourcing
• R&D teams reformulating existing EU-approved medicines
• International companies seeking French/EU market entry
• Biotech & specialty pharma developers