🇮🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Ireland

HPRA & 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 tailored specifically for regulatory submissions in Ireland and across the European Union (EU).

All services strictly comply with:

• HPRA (Health Products Regulatory Authority) BE & Clinical Trial 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, GLP & GMP (Annex 13)

• European Pharmacopoeia (Ph. Eur.)

Ireland is a major pharmaceutical hub in Western Europe, hosting global innovators, generics, and biotech companies — making high-quality BA/BE support essential for EU and international submissions.

💊 Core BA/BE Services for Ireland & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted per HPRA, EMA, and EU-GCP requirements.
• Single-dose & multiple-dose BE studies (crossover or parallel).
• Studies in healthy volunteers and patient populations where required.
• Ethical approval via Irish Research Ethics Committees under EU-CTR 536/2014.
• Protocol design aligned with ICH E6 (R2), EMA BE guidelines & Ph. Eur.

Comparative Dissolution Profiling (CDP)

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

IVIVC & Biowaiver Support

• BCS-based biowaiver justification aligned with EMA & ICH Q6A.
• Level A/B/C IVIVC modeling for predictive PK-dissolution correlation.
• Supports waiver of clinical BE studies for BCS Class I & III where justified.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV bioanalytical method development.
• Validation following ICH M10, accepted in all EU member states.
• Stability-indicating analytical methods for APIs & finished products.
• Rigorous evaluation of precision, accuracy, linearity, stability & selectivity.

Pharmacokinetic (PK) & BE Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• EMA-regulated BE acceptance limits: 90% CI within 80.00–125.00%.
• Scaled BE methodologies for Highly Variable Drugs (HVDs).
• Sample size & statistical power calculations per EMA guidelines.

📑 HPRA- & EMA-Ready CTD Documentation

We prepare complete EU CTD documentation including:

• 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 (CDP) Report
• CTD Modules 1–5 for:

• EU Generic submissions (Article 10)

• Decentralized Procedure (DCP)

• Mutual Recognition Procedure (MRP)

• Centralized Procedure (CP)

✨ Why Choose BioEquiGlobal for Ireland?

• Strong Pharmaceutical Ecosystem: Ireland is home to many global pharma and biotech companies, ensuring high-quality collaboration and infrastructure.
• EMA-Aligned Expertise: All study designs, protocols & documentation meet EMA regulatory expectations.
• Strict GCP/GLP/GMP Compliance: Ensures global acceptance for submissions beyond the EU (USFDA, MHRA, TGA, Health Canada).
• Efficient for Pan-EU Approvals: BE data generated for Ireland supports approval across all EU/EEA markets.
• End-to-End BE Support: From planning and protocol development to PK/BE analysis and CTD submission.

🗺️ BA/BE Study Workflow for Ireland / EU Sponsors

1. Feasibility Review & Regulatory Mapping
   (EMA guidelines, reference selection, biowaiver feasibility)

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

3. Analytical Method Development & Validation
   (LC-MS/MS validated per ICH M10)

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

5. Bioanalysis & PK/BE Interpretation
   (NCA, statistical BE assessments, HVD scaled BE if required)

6. Final CTD Documentation for HPRA/EMA
   (CSR, CDP, validation package & CTD Modules)

Who We Support in Ireland & Across Europe

• Generic pharmaceutical manufacturers
• Marketing Authorization Holders (MAHs) filing via DCP/MRP/CP
• CROs outsourcing bioanalytical or PK/BE work
• R&D teams reformulating authorized EU products
• Export-oriented pharma companies entering the EU
• Specialty pharma & biotech innovators