🇸🇰 Bioavailability & Bioequivalence (BA/BE) Studies Services for Slovakia

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

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

All services comply with:

• ŠÚKL (Štátny ústav pre kontrolu liečiv) BE & clinical trial regulations

• 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.)

Slovakia is an emerging European centre for cost-effective, high-quality BA/BE studies with efficient ethics and regulatory timelines.

💊 Core BA/BE Services for Slovakia & EU Submissions

Clinical BA/BE Studies (Human)

• Conducted per ŠÚKL, EMA, and EU-GCP requirements.
• Single-dose & multiple-dose BE studies using crossover or parallel designs.
• Healthy volunteer studies or patient-based trials depending on drug class.
• Ethics approval via Slovak Ethics Committees, aligned with EU-CTR 536/2014.
• Protocols prepared per EMA BE guidelines, ICH E6 (R2) & Ph. Eur. standards.

Comparative Dissolution Profiling (CDP)

• Mandatory for EU generic submissions (Directive 2001/83/EC, Article 10).
• Dissolution testing using Ph. Eur., USP, EP & biorelevant media.
• f2 similarity factor analysis for dissolution comparability.
• Model-independent & model-dependent dissolution modeling.

IVIVC & Biowaiver Services

• BCS-based biowaiver justification per EMA Biowaiver Guidance & ICH Q6A.
• Level A/B/C IVIVC modeling to support PK predictability.
• Waiver support for eligible BCS Class I & III products.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV method development and validation.
• Validation performed according to ICH M10, accepted by ŠÚKL & EMA.
• Stability-indicating methods for APIs & pharmaceutical products.
• Comprehensive validation: accuracy, precision, stability, selectivity & linearity.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• BE acceptance limits 80.00–125.00% (90% CI) per EMA.
• Scaled BE for Highly Variable Drugs (HVDs).
• PK modeling, power analysis, and optimal sample-size estimation.

📑 ŠÚKL- & EMA-Ready CTD Documentation

We prepare full regulatory documentation aligned with Slovak and EU requirements:

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

• Strong EU Clinical Research Environment: Slovakia offers efficient regulatory pathways, strong site infrastructure, and high volunteer availability.
• EMA-Aligned Regulatory Compliance: All studies follow EMA BE guidelines and EU standards.
• Full-Quality Assurance: GCP-, GLP-, and GMP-compliant systems ensure global acceptability.
• Central Location Within Europe: Suitable for multicentric EU clinical development programs.
• End-to-End Support: From feasibility and protocol development to BE analysis and CTD dossier completion.

🗺️ BA/BE Study Workflow for Slovakia-Based Sponsors

1. Feasibility & BE Strategy Review
   (Reference product assessment, biowaiver evaluation, EMA guideline mapping)

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

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

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

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

6. Final CTD Documentation
   (CSR, dissolution profiles, validation package & CTD Modules 1–5)

Who We Support in Slovakia & Across the EU

• Generic medicine manufacturers
• EU Marketing Authorization Holders (MAHs)
• CROs requiring PK/bioanalytical outsourcing
• R&D centers reformulating EU-authorized medicines
• Export-oriented pharmaceutical manufacturers
• Biotech & specialty pharma innovators