🇨🇾 Bioavailability & Bioequivalence (BA/BE) Studies Services for Cyprus

CY MDA & EMA-Compliant BA/BE Studies & 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 pharmaceutical submissions to the Cyprus Medicines and Medical Devices Authority (CY MDA).

Cyprus follows a harmonized EU regulatory system; therefore, our services comply with:

• CY MDA Requirements for Medicinal Product Registration

• 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, EU-GLP & EU-GMP (Annex 13)

• European Pharmacopoeia (Ph. Eur.)

Cyprus is a strategically important EU jurisdiction with efficient regulatory processes, multilingual capabilities, and widespread reliance on EMA-aligned scientific standards.

💊 Core BA/BE Services for Cyprus & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted according to CY MDA, EMA & EU-GCP.
• Single- and multiple-dose BE studies using crossover or parallel designs.
• Healthy volunteer and patient-based PK studies.
• Ethical review through Cyprus National Bioethics Committee, aligned with EU-CTR.
• Protocols developed per ICH E6 (R2) and EMA BE guidelines.

Comparative Dissolution Profiling (CDP)

• Required for EU generic submissions (Article 10).
• Dissolution testing using Ph. Eur., USP, and biorelevant media.
• Similarity factor (f2) evaluation for comparative dissolution.
• Model-dependent and model-independent dissolution analyses.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification per EMA & ICH Q6A.
• Level A/B/C IVIVC modeling for predictive dissolution–PK correlations.
• Suitable for BCS Class I & III drugs.

Analytical Method Development & Validation

• Analytical method development using LC-MS/MS & HPLC-UV.
• Validation per ICH M10, accepted by CY MDA & EMA.
• Stability-indicating analytical methods for APIs & finished products.
• Validation parameters: accuracy, precision, linearity, selectivity & stability.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• EMA standard BE acceptance limits: 90% CI within 80–125%.
• Scaled BE approach for Highly Variable Drugs (HVDs).
• Sample-size and power calculations based on EMA/ICH statistics.

📑 Cyprus (CY MDA)–Ready CTD Documentation

We prepare complete CTD modules for Cyprus and EU submissions:

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

• Cyprus-specific Module 1

• Generic medicine dossier (Article 10)

• DCP/MRP pathway documentation

• Centralized Procedure (CP) components where applicable

✨ Why Choose BioEquiGlobal for Cyprus?

• EMA-Aligned BE Expertise: Ensures high acceptance across EU/EEA markets.
• Strong Regulatory Efficiency: Cyprus offers rapid review for EU-CTR and CTD filings.
• High Quality Standards: GCP/GLP/GMP-driven processes ensure global regulatory acceptance.
• Expertise in Complex BE Requirements: MR formulations, HVDs, ophthalmic, inhalation, injectables & topicals.
• End-to-End Regulatory Support: From feasibility assessment to PK interpretation and CTD dossier preparation.

🗺️ BA/BE Study Workflow for Cyprus / EU Sponsors

1. Feasibility & Regulatory Mapping
   (Reference product verification, EMA BE guideline alignment, biowaiver assessment)

2. Protocol Design & Ethics Approval
   (Submission to the Cyprus National Bioethics Committee under EU-CTR)

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

4. Clinical Study Execution
   (Volunteer recruitment, dosing, PK sampling under EU-GCP)

5. Bioanalysis & PK/BE Assessment
   (NCA, BE statistics including scaled BE for HVDs)

6. Cyprus/EU-Ready CTD Documentation
   (CSR, CDP, validation package & complete CTD Modules 1–5)

Who We Support in Cyprus & Across the EU

• Generic pharmaceutical manufacturers
• Companies applying via DCP, MRP, CP pathways
• CROs requiring analytical or clinical outsourcing
• EU-based and international manufacturers entering the Cyprus market
• Biotech & specialty pharma innovators
• R&D departments reformulating EU-approved products