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🇨🇿 Bioavailability & Bioequivalence (BA/BE) Studies Services for the Czech Republic

SÚKL & EMA-Compliant BA/BE & 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, fully aligned with the regulatory standards of the Czech Republic and the broader European Union (EU).

All service processes follow:

• SÚKL (Státní ústav pro kontrolu léčiv) regulatory 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.)

The Czech Republic is one of Europe’s strongest clinical research hubs, known for high-quality clinical trial infrastructure, experienced investigators, and efficient regulatory processes under SÚKL.

💊 Core BA/BE Services for Czech Republic & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted per SÚKL, EMA, and EU-GCP requirements.
• Single-dose & multiple-dose BE studies with crossover or parallel designs.
• Studies in healthy volunteers or patient populations where applicable.
• Ethical approval via Czech Ethics Committees, aligned with EU-CTR 536/2014.
• Protocols developed according to ICH E6 (R2) and EMA BE guidelines.

Comparative Dissolution Profiling (CDP)

• Required for generic submissions under EU Directive 2001/83/EC (Article 10).
• Dissolution testing using Ph. Eur., USP, EP & biorelevant media.
• Similarity factor (f2) for dissolution profile comparison.
• Model-independent & kinetic dissolution analyses performed as needed.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification per EMA Biowaiver Guidance & ICH Q6A.
• Level A, B, and C IVIVC modeling to correlate PK and dissolution.
• Eligible for BCS Class I & III drugs following EU criteria.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV analytical methods.
• Validation in full compliance with ICH M10—recognized by SÚKL and EMA.
• Stability-indicating methods for APIs and finished dosage forms.
• Complete validation: accuracy, precision, linearity, specificity, and stability.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, etc.).
• EMA-standard BE acceptance limits: 90% CI within 80.00–125.00%.
• Scaled average BE modeling for Highly Variable Drugs (HVDs).
• Sample-size & statistical power optimization.

📑 SÚKL- & EMA-Ready CTD Documentation

We prepare full CTD submission packages for the Czech Republic and the EU:

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

• Highly Developed Clinical Research Sector: The Czech Republic is recognized for excellence in EU-regulated clinical trials.
• EMA-Aligned BE Expertise: Ensures seamless approval across EU/EEA markets.
• Strong Regulatory Compliance: All activities follow EMA, ICH, and EU quality standards.
• Strategic European Location: Ideal for sponsors targeting the EU pharmaceutical market.
• End-to-End Support: From feasibility assessment to PK/BE analysis and CTD submission.

🗺️ BA/BE Study Workflow for Czech Republic / EU Sponsors

1. Feasibility Assessment & EMA/SÚKL Guideline Mapping
   (Reference product verification, biowaiver evaluation)

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

3. Analytical Method Development & Validation
   (Conducted per ICH M10)

4. Clinical Study Execution in the Czech Republic
   (Volunteer recruitment, dosing, PK sampling & monitoring 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 Czech Republic & Across Europe

• Generic pharmaceutical manufacturers
• Marketing Authorization Holders (MAHs) using DCP, MRP, CP
• CROs outsourcing analytical or BE activities
• R&D & formulation development teams
• Pharma companies entering EU/EEA markets
• Biotech & specialty pharmaceutical organizations