🇦🇹 Bioavailability & Bioequivalence (BA/BE) Studies Services for Austria

BASG/AGES & EMA-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers full Bioavailability (BA) and Bioequivalence (BE) study services, as well as Comparative Dissolution Profiling, tailored for regulatory submissions in Austria and across the European Union (EU).

All services comply with:

• BASG/AGES – Austrian Medicines Agency Requirements

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

• EU Clinical Trial Regulation (CTR) 536/2014

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

• EU-GCP, EU-GLP & EU-GMP (Annex 13)

• European Pharmacopoeia (Ph. Eur.)

Austria is recognized for its rigorous regulatory standards, experienced clinical research centers, and strong compliance culture, making it a strategic location for EU-focused BA/BE programs.

💊 Core BA/BE Services for Austria & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted according to BASG, EMA, and EU-GCP requirements.
• Single-dose & multiple-dose BE studies (crossover or parallel).
• Healthy volunteer & patient-based studies depending on therapeutic need.
• Ethical approval through Austrian Ethics Committees, aligned with EU-CTR 536/2014.
• Protocol development aligned with ICH E6 (R2) and EMA BE expectations.

Comparative Dissolution Profiling (CDP)

• Required for generic (Article 10) EU submissions.
• Dissolution testing per Ph. Eur., USP, and biorelevant media.
• Similarity factor (f2) analysis for dissolution equivalence.
• Both model-independent & model-dependent dissolution evaluations.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification per EMA biowaiver guidance & ICH Q6A.
• Level A/B/C IVIVC modeling to relate in vitro dissolution and in vivo PK.
• Biowaiver support for eligible BCS Class I & III drugs.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV based analytical methods.
• Validation per ICH M10, fully accepted in Austria & across the EU.
• Stability-indicating analytical methods for APIs & finished medicines.
• Accuracy, precision, linearity, specificity & stability assessments ensured.

Pharmacokinetic (PK) & BE Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• EMA acceptance criteria: 90% CI within 80.00–125.00%.
• Scaled BE methodology for Highly Variable Drugs (HVDs).
• Sample-size & statistical power calculation per EMA guidance.

📑 Austria- & EMA-Ready CTD Documentation

We prepare complete CTD documentation packages for submissions to BASG/AGES and EU procedures:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per ICH E3 and EMA guidelines
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile (CDP) Report
• CTD Modules 1–5 for:

• Generic applications (Article 10)

• DCP – Decentralized Procedure

• MRP – Mutual Recognition Procedure

• CP – Centralized Procedure

✨ Why Choose BioEquiGlobal for Austria?

• High Regulatory Rigor: BASG/AGES is known for strict scientific evaluation and robust documentation standards.
• EMA-Aligned Expertise: Ensures pan-European acceptance of generated BE data.
• Strong Quality Culture: GCP-, GLP-, and GMP-driven systems guarantee global compliance.
• Strategic EU Location: Ideal for multinational sponsors seeking EU-wide or DCP/MRP submissions.
• End-to-End Support: From feasibility and protocol design to clinical execution, PK/BE analysis & final CTD dossier preparation.

🗺️ BA/BE Study Workflow for Austria / EU Sponsors

1. Feasibility & BE Strategy Assessment
   (Reference product selection, EMA guideline mapping, biowaiver eligibility)

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

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

4. Clinical Study Execution in Austria
   (Volunteer recruitment, dosing, PK sampling & GCP monitoring)

5. Bioanalysis & PK/BE Interpretation
   (NCA, statistical BE assessment, scaled BE if required)

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

Who We Support in Austria & Across Europe

• Generic medicine manufacturers
• MAH holders using DCP, MRP & CP routes
• CROs outsourcing analytical or PK/BE work
• R&D teams reformulating EU-approved products
• International pharma entering the EU market
• Biotech & specialty pharmaceutical companies