🇩🇰 Bioavailability & Bioequivalence (BA/BE) Studies Services for Denmark

Danish Medicines Agency (Lægemiddelstyrelsen) & EMA-Compliant BA/BE Studies — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for pharmaceutical companies preparing regulatory submissions in Denmark and the broader European Union (EU).

All services comply with:

• Danish Medicines Agency (Lægemiddelstyrelsen) Clinical Trial & BE Requirements

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

• EU Clinical Trial Regulation (CTR) 536/2014

• ICH Guidelines (E6 R2, E8, Q2, Q6A, M10)

• EU-GCP, EU-GLP & EU-GMP (Annex 13)

• European Pharmacopoeia (Ph. Eur.)

Denmark is a leading Northern European hub with world-class clinical infrastructure, highly experienced research institutions, and robust regulatory oversight — making it ideal for BA/BE studies intended for EU-wide submissions.

💊 Core BA/BE Services for Denmark & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted according to Lægemiddelstyrelsen, EMA & EU-GCP requirements.
• Single-dose & multiple-dose BE studies using crossover or parallel designs.
• Healthy volunteers or patient populations depending on therapeutic indication.
• Ethics approval through Danish National Committee on Health Research Ethics under EU-CTR 536/2014.
• Protocols prepared in line with ICH E6 (R2), EMA BE guidance & Ph. Eur.

Comparative Dissolution Profiling (CDP)

• Essential for EU generic applications (Article 10).
• Testing performed using Ph. Eur., USP, and biorelevant dissolution media.
• Calculation of similarity factor (f2) for dissolution equivalence.
• Model-independent & model-dependent release profile comparisons.

IVIVC & Biowaiver Support

• BCS-based biowaiver support per EMA biowaiver guidelines & ICH Q6A.
• Level A/B/C IVIVC modeling to predict PK parameters from dissolution data.
• Waiver support for applicable BCS Class I & III medicines.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV analytical methods.
• Validation aligned with ICH M10 – accepted across all EU authorities.
• Stability-indicating methods for APIs & finished dosage forms.
• Full validation: accuracy, precision, stability, selectivity & linearity.

Pharmacokinetic (PK) & Statistical BE Evaluation

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• EMA BE acceptance limits: 90% CI between 80.00–125.00%.
• Support for scaled BE for Highly Variable Drugs (HVDs).
• Power & sample-size calculations based on EMA expectations.

📑 Denmark- & EMA-Ready CTD Documentation

We prepare complete documentation packages required for Danish and EU submissions:

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

• High-Quality Clinical Environment: Denmark is known for precise execution, expert investigators & strong regulatory compliance.
• EMA-Aligned BE Expertise: All study designs and documents fully comply with EMA bioequivalence standards.
• Strict QA & Compliance: GCP-, GLP-, GMP-driven operations ensure global acceptance of data.
• Strategic Northern Europe Location: Ideal for EU submissions requiring reproducibility and high data integrity.
• End-to-End Support: From feasibility to BE execution, PK analysis, and final EU CTD dossier preparation.

🗺️ BA/BE Study Workflow for Denmark / EU Sponsors

1. Feasibility & Regulatory Gap Assessment
   (EMA guideline mapping, reference product evaluation, biowaiver feasibility)

2. Protocol Development & Ethics Approval
   (Submission to Danish Ethics Committees under EU-CTR)

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

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

5. Bioanalysis & PK/BE Interpretation
   (PK modeling, BE statistics, HVD support if needed)

6. Final Documentation & CTD Submission
   (CSR, dissolution profiles, validation package & CTD Modules)

Who We Support in Denmark & Across the EU

• Generic pharmaceutical manufacturers
• EU MAH applicants filing through DCP/MRP/CP
• CROs requiring PK or bioanalytical outsourcing
• R&D teams reformulating existing EU medicines
• Export-oriented pharma companies entering the EU market
• Biotech & specialty pharma innovators