🇲🇹 Bioavailability & Bioequivalence (BA/BE) Studies Services for Malta

Malta Medicines Authority (MMA) & EMA-Compliant BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA) and Bioequivalence (BE) study services, alongside Comparative Dissolution Profiling, aligned with the Malta Medicines Authority (MMA) and the broader European Medicines Agency (EMA).

All studies adhere to:

• Malta Medicines Authority (MMA) Clinical Trial & BE Requirements

• 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.)

Malta is a rapidly developing EU pharmaceutical hub known for efficient regulatory processes, centralized ethics systems, and strong alignment with EMA standards.

💊 Core BA/BE Services for Malta & EMA Submissions

Clinical BA/BE Studies (Human)

• Conducted according to MMA, EMA, and EU-GCP guidance.
• Single-dose and multiple-dose BE studies (crossover or parallel).
• Healthy volunteer and patient-based BE studies as needed.
• Ethical approval via Central Ethics Committee under EU-CTR 536/2014.
• Protocol design aligned with ICH E6 (R2) and EMA BE guidelines.

Comparative Dissolution Profiling (CDP)

• Required for generic applications (Article 10).
• Dissolution testing per Ph. Eur., USP, and biorelevant media.
• Similarity factor (f2) for dissolution equivalence.
• Model-independent & kinetic dissolution modeling.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification per EMA & ICH Q6A.
• Level A/B/C IVIVC modeling for mechanistic PK–dissolution correlation.
• Applicable to BCS Class I & III biowaiver submissions.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV analytical method development.
• Validation fully compliant with ICH M10, accepted by MMA & EMA.
• Stability-indicating assay development for APIs & finished products.
• Validation of precision, accuracy, linearity, selectivity & stability.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• EMA standard BE acceptance limits: 90% CI between 80–125%.
• Scaled BE for Highly Variable Drugs (HVDs).
• Power analysis & sample-size calculations per EMA statistics criteria.

📑 Malta Medicines Authority–Ready CTD Documentation

We prepare complete CTD dossiers suitable for Malta and EU submissions:

• 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, including:

• Malta-specific Module 1

• Generic applications (Article 10)

• DCP (Decentralized Procedure)

• MRP (Mutual Recognition Procedure)

• CP (Centralized Procedure)

✨ Why Choose BioEquiGlobal for Malta?

• MMA & EMA Alignment: All studies follow the expectations of Maltese and EU regulators.
• Strong Compliance & Quality: GCP, GLP & GMP-based operations ensure international acceptability.
• Efficient EU Pathways: Malta is well-positioned for DCP/MRP submissions among EU member states.
• Expertise in Complex Generics: MR dosage forms, HVDs, ophthalmics, inhalation, topicals & injectables.
• End-to-End BE Capability: From feasibility assessment & protocol drafting to PK analysis and CTD dossier finalization.

🗺️ BA/BE Study Workflow for Malta / EU Sponsors

1. Feasibility & Regulatory Evaluation
   (Reference product identification, EMA guideline mapping, biowaiver feasibility)

2. Protocol Development & Ethics Approval (EU-CTR)
   (Submission to Malta’s Central Ethics Committee)

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

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

5. Bioanalysis & PK/BE Evaluation
   (NCA, BE statistical calculations, scaled BE where applicable)

6. CTD Documentation Preparation
   (CSR, CDP, validation reports & full CTD Modules for Malta/MMA)

Who We Support in Malta & Across Europe

• EU generic medicine manufacturers
• MAH applicants submitting via DCP, MRP & CP
• CROs requiring analytical or PK/BE outsourcing
• R&D teams reformulating medicines for EU markets
• Export-oriented pharmaceutical companies targeting Europe
• Biotech & specialty pharma innovators