🇱🇹 Bioavailability & Bioequivalence (BA/BE) Studies Services for Lithuania

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

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides full Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for regulatory submissions in Lithuania and across the European Union (EU).

All services comply with:

• VVKT (Valstybinė Vaistų Kontrolės Tarnyba) — State Medicines Control Agency of Lithuania

• 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, GLP & GMP (Annex 13)

• European Pharmacopoeia (Ph. Eur.)

Lithuania is an efficient and rapidly growing location for EU clinical trials, known for its high-quality research environment and streamlined regulatory timelines under VVKT.

💊 Core BA/BE Services for Lithuania & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted as per VVKT, EMA, and EU-GCP guidelines.
• Single-dose & multiple-dose BE study designs (crossover or parallel).
• Healthy volunteer studies or patient PK studies depending on the therapeutic area.
• Ethical approval through Lithuanian Bioethics Committees under EU-CTR 536/2014.
• Protocol development aligned with ICH E6 (R2) and EMA BE guidelines.

Comparative Dissolution Profiling (CDP)

• Essential for EU generic submissions (Article 10, Directive 2001/83/EC).
• Dissolution testing using Ph. Eur., USP and biorelevant media.
• Similarity factor (f2) calculation for dissolution comparison.
• Model-independent & kinetic dissolution modelling as per EMA criteria.

IVIVC & Biowaiver Support

• EMA-aligned BCS-based biowaiver preparation for eligible APIs.
• Level A, B, and C IVIVC modeling to correlate dissolution & PK behavior.
• Biowaiver suitability assessment for BCS Class I & III drugs.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV analytical method development and validation.
• Fully compliant with ICH M10 and recognized by VVKT/EMA.
• Stability-indicating methods for APIs and finished pharmaceutical products.
• Full validation: accuracy, precision, specificity, linearity & stability.

Pharmacokinetic (PK) & BE Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, etc.).
• EMA standard BE acceptance criteria: 90% CI within 80.00–125.00%.
• Scaled average BE for Highly Variable Drugs (HVDs) when applicable.
• Power & sample-size calculations per EMA statistical guidance.

📑 VVKT- & EMA-Ready CTD Documentation

We prepare comprehensive submission-ready CTD documentation:

• 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 Lithuania?

• Efficient Baltic Regulatory Environment: Lithuania offers fast ethics & regulatory approval timelines under VVKT.
• Full EMA Alignment: All BA/BE methodologies and documents satisfy EMA’s latest BE guidelines.
• High Scientific Quality: GCP-, GLP-, and GMP-compliant systems ensure global acceptability.
• Perfect for Pan-EU Submissions: BE studies conducted for Lithuania are valid across all EU/EEA markets.
• End-to-End BE Expertise: From feasibility & protocol design to PK/BE analysis and CTD dossier preparation.

🗺️ BA/BE Study Workflow for Lithuania / EU Sponsors

1. Feasibility & Regulatory Assessment
   (Reference product, EMA guidelines, biowaiver eligibility review)

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

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

4. Clinical Study Execution in Lithuania
   (Recruitment, dosing, PK sampling & GCP-compliant monitoring)

5. Bioanalysis & PK/BE Interpretation
   (NCA, BE statistics, scaled BE where needed)

6. Complete CTD Documentation Submission
   (CSR, CDP, analytical validation & full CTD Modules)

Who We Support in Lithuania & Across the EU

• Generic pharmaceutical manufacturers
• EU MAH applicants (DCP/MRP/CP pathways)
• CROs outsourcing analytical or PK/BE functions
• R&D teams reformulating existing EU medicines
• Export-focused pharma manufacturers entering EU markets
• Biotech & specialty pharma companies