🇸🇮 Bioavailability & Bioequivalence (BA/BE) Studies Services for Slovenia

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

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers comprehensive Bioavailability (BA) and Bioequivalence (BE) studies, along with Comparative Dissolution Profiling, tailored for pharmaceutical submissions to JAZMP, Slovenia’s national medicines authority.

All study services fully comply with:

• JAZMP Regulatory Requirements for Medicinal Products

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

• EU Clinical Trial Regulation (EU-CTR 536/2014)

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

• EU-GCP, GLP & GMP (Annex 13)

• European Pharmacopoeia (Ph. Eur.)

Slovenia is an EU member with a well-developed regulatory and clinical research ecosystem, and its BE data is accepted across all EU/EEA markets.

💊 Core BA/BE Services for Slovenia & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted in accordance with JAZMP, EMA & EU-GCP guidelines.
• Single-dose & multiple-dose BE studies (crossover and parallel).
• Healthy volunteer studies or patient-based PK studies when needed.
• Ethical approval through Slovenian National Medical Ethics Committee, under EU-CTR.
• Protocols designed per ICH E6 (R2) and EMA BE requirements.

Comparative Dissolution Profiling (CDP)

• Required for generic submissions under EU Directive 2001/83/EC, Article 10.
• Dissolution studies conducted using Ph. Eur., USP, and biorelevant media.
• Similarity factor (f2) calculations for profile comparison.
• Model-independent & model-dependent dissolution analysis.

IVIVC & Biowaiver Support

• EMA-aligned BCS-based biowaiver justifications (ICH Q6A-compliant).
• Level A/B/C IVIVC modeling for predicting in vivo PK from in vitro dissolution.
• Suitable for BCS Class I & III medicines as per EMA rules.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV analytical method development.
• Full ICH M10-compliant validation accepted by JAZMP & EMA.
• Stability-indicating method development for APIs & finished products.
• Validation of precision, accuracy, linearity, specificity & stability.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK calculations (AUC, Cmax, Tmax, t½).
• EMA BE acceptance limits (90% CI within 80.00–125.00%).
• Scaled average BE for Highly Variable Drugs (HVDs).
• Power & sample-size calculations per EMA statistical guidance.

📑 JAZMP- & EMA-Ready CTD Documentation

We prepare complete CTD submission packages suitable for Slovenia and entire EU markets:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) – ICH E3 & EMA format
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile (CDP) Report
• CTD Modules 1–5, supporting:

• EU Generic Medicinal Product Applications (Article 10)

• DCP – Decentralized Procedure

• MRP – Mutual Recognition Procedure

• CP – Centralized Procedure

✨ Why Choose BioEquiGlobal for Slovenia?

• EMA-Aligned Expertise: Ensures BE packages are fully acceptable across EU markets.
• High Clinical Research Standards: Slovenia offers robust infrastructure and experienced clinical trial units.
• Regulatory Excellence: JAZMP is known for scientific rigor and efficient communication.
• Support for Complex Generics: Including MR formulations, HVDs, inhalation, ophthalmic, topicals & injectables.
• End-to-End BE Support: From feasibility & protocol development to PK/BE statistics and CTD dossier finalization.

🗺️ BA/BE Study Workflow for Slovenia / EU Sponsors

1. Feasibility & Regulatory Strategy
   (Reference product verification, EMA guideline mapping, biowaiver evaluation)

2. Protocol Development & Ethics Committee Review
   (Submission to Slovenia's National Medical Ethics Committee under EU-CTR)

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

4. Clinical Study Execution in Slovenia
   (Volunteer recruitment, dosing, PK sampling under strict 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 Slovenia & Across the EU

• Generic pharmaceutical manufacturers
• EU MAH applicants using DCP, MRP & CP
• CROs requiring BA/BE or bioanalytical outsourcing
• R&D teams reformulating EU-authorized medicines
• International pharma companies entering the EU market
• Biotech & specialty pharma innovators