🇳🇱 Bioavailability & Bioequivalence (BA/BE) Studies Services for the Netherlands

CBG-MEB & EMA-Compliant BA/BE Studies & 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 regulatory submissions in the Netherlands under the CBG-MEB and the European Medicines Agency (EMA).

All services comply with:

• CBG-MEB (College ter Beoordeling van Geneesmiddelen) regulatory requirements

• EMA Guideline on the Investigation of Bioequivalence (2010/2022)

• 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.)

The Netherlands is one of Europe’s most efficient and innovation-driven clinical research environments, with fast ethics approvals, strong regulatory governance, and internationally respected data quality.

💊 Core BA/BE Services for the Netherlands & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted according to CBG-MEB, EMA, and EU-GCP guidelines.
• Single-dose & multiple-dose BE studies (crossover or parallel).
• Healthy volunteer studies or patient-specific PK studies.
• Approval via Dutch Ethical Review Committees (METC) under EU-CTR.
• Protocol development aligned with ICH E6 (R2) and EMA BE requirements.

Comparative Dissolution Profiling (CDP)

• Required for EU generic applications (Article 10).
• Dissolution testing using Ph. Eur., USP, EP & biorelevant media (FaSSIF/FeSSIF).
• Similarity factor (f2) calculations to establish dissolution equivalence.
• Model-dependent & model-independent dissolution analysis.

IVIVC & Biowaiver Support

• BCS-based biowaiver assessment per EMA & ICH Q6A guidance.
• Level A/B/C IVIVC modeling for predictive dissolution-PK correlation.
• Suitable for BCS Class I & III drug biowaivers.

Analytical Method Development & Validation

• Bioanalytical method development via LC-MS/MS & HPLC-UV systems.
• Full validation as per ICH M10, accepted by CBG-MEB & EMA.
• Stability-indicating analytical method development for APIs & finished forms.
• Comprehensive validation for accuracy, precision, linearity, selectivity & stability.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• Standard EMA BE limits: 90% CI within 80.00–125.00%.
• Scaled BE approaches for Highly Variable Drugs (HVDs).
• Power & sample-size calculations per EMA statistical guidelines.

📑 CBG-MEB- & EMA-Ready CTD Documentation

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

• 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 the Netherlands?

• Top-Tier Clinical Trial Environment: The Netherlands is one of Europe’s most efficient countries for initiating clinical studies.
• CBG-MEB & EMA Alignment: Ensures that BE data generated are accepted across all EU/EEA markets.
• High Data Integrity & Compliance: Strict adherence to GCP/GLP/GMP quality systems.
• Expertise in Complex Generics: Including MR formulations, HVDs, inhalation products, ophthalmics, injectables & topicals.
• Complete BE Support: From feasibility to PK analysis, BE statistics & full CTD dossier creation.

🗺️ BA/BE Study Workflow for Netherlands / EU Sponsors

1. Feasibility & Regulatory Strategy
   (Reference product identification, EMA guideline mapping, biowaiver feasibility)

2. Protocol Development & Ethics Committee Review (METC)
   (EU-CTR compliant submissions)

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

4. Clinical Study Execution in the Netherlands
   (Volunteer/patient recruitment, dosing, PK sampling under GCP)

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

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

Who We Support in the Netherlands & Across Europe

• Generic pharmaceutical manufacturers
• EU MAH applicants using DCP, MRP & CP
• CROs needing analytical or PK/BE outsourcing
• R&D teams reformulating EU-approved medicines
• Export-oriented pharma entering EU markets
• Biotech & specialty pharma companies