🇩🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Germany

BfArM / PEI & EMA-Compliant BA/BE Studies & 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, tailored for regulatory submissions in Germany under BfArM and PEI (for biologics).

Our studies comply fully with:

• BfArM (Federal Institute for Drugs and Medical Devices) BE Requirements

• PEI (Paul-Ehrlich-Institut) for biological & advanced therapies

• 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.)

Germany is one of Europe’s top clinical research ecosystems, known for scientific rigor, regulatory transparency, and robust data quality standards.

💊 Core BA/BE Services for Germany & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted according to BfArM, EMA and EU-GCP requirements.
• Single-dose and multiple-dose BE studies using crossover/parallel designs.
• Healthy volunteer or patient studies depending on product class.
• Ethical approval through German Ethics Committees (Ethikkommission) under 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 using Ph. Eur., USP, EP & biorelevant media.
• Similarity factor (f2) assessment for dissolution equivalence.
• Both model-dependent & model-independent dissolution analyses.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification per EMA guidance & ICH Q6A.
• Level A/B/C IVIVC modeling for dissolution–PK predictability.
• Suitable for BCS Class I & III biowaiver applications.

Analytical Method Development & Validation

• Bioanalytical methods developed using LC-MS/MS & HPLC-UV.
• Full validation as per ICH M10, accepted by BfArM/EMA.
• Stability-indicating methods for APIs & formulations.
• Complete validation covering precision, accuracy, linearity, selectivity & stability.

Pharmacokinetic (PK) & BE Statistical Analysis

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

📑 BfArM- & EMA-Ready CTD Documentation

We prepare complete submission-ready CTD documentation for Germany and the EU:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per ICH E3 & EMA requirements
• 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 Germany?

• German Research Excellence: Germany hosts some of the world’s top clinical research sites and CROs.
• EMA & BfArM-Aligned Expertise: Ensures BE studies meet the highest regulatory standards.
• Robust Quality & Compliance Culture: GCP/GLP/GMP-aligned processes ensure global acceptance.
• Specialized in Complex Generics: MR products, HVDs, topicals, inhalation, ophthalmic, injectables & more.
• End-to-End BE Delivery: From feasibility assessment & protocol development to PK/BE analysis and full CTD dossier preparation.

🗺️ BA/BE Study Workflow for Germany / EU Sponsors

1. Feasibility & Regulatory Strategy
   (Reference product mapping, EMA guideline application, biowaiver assessment)

2. Protocol Development & Ethics Committee Submission
   (EU-CTR compliant submission to German Ethics Committees)

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

4. Clinical Study Execution in Germany
   (Volunteer recruitment, dosing, sampling & safety monitoring under GCP)

5. Bioanalysis & PK/BE Interpretation
   (NCA + BE statistical evaluation, scaled BE for HVDs)

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

Who We Support in Germany & Across Europe

• Generic drug manufacturers
• MAH applicants using DCP, MRP & CP routes
• CROs requiring PK/bioanalytical outsourcing
• R&D units reformulating EU-approved drugs
• International companies targeting the German or EU markets
• Biotech & specialty pharma companies