🇵🇹 Bioavailability & Bioequivalence (BA/BE) Studies Services for Portugal
INFARMED & 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, designed specifically for regulatory submissions to INFARMED and the European Medicines Agency (EMA).
All studies fully comply with:
INFARMED Clinical Trial & Bioequivalence 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.)
Portugal is a rapidly growing EU center for clinical research, with strong regulatory reliability, fast ethics review, and high-quality clinical infrastructures.
💊 Core BA/BE Services for Portugal & EMA Submissions
Clinical BA/BE Studies (Human)
• Conducted according to INFARMED, EMA, and EU-GCP requirements.
• Single-dose and multiple-dose BE studies (crossover/parallel).
• Healthy volunteer or patient-based PK studies depending on therapeutic class.
• Ethical approval through Portuguese Ethics Committees (CEIC) under EU-CTR.
• Protocols developed in compliance with ICH E6 (R2) and EMA BE guidance.
Comparative Dissolution Profiling (CDP)
• Required for EU generic applications (Article 10).
• Dissolution per Ph. Eur., USP, and biorelevant conditions.
• Similarity factor (f2) for comparing test and reference dissolution profiles.
• Model-independent and model-dependent release analysis.
IVIVC & Biowaiver Support
• BCS-based biowaiver justification per EMA & ICH Q6A.
• Level A/B/C IVIVC modeling for predictive PK–dissolution correlation.
• Suitable for BCS Class I & III drug submissions.
Analytical Method Development & Validation
• Bioanalytical development via LC-MS/MS & HPLC-UV.
• Method validation per ICH M10, fully accepted by INFARMED & EMA.
• Stability-indicating analytical method development for APIs & finished formulations.
• Validation for precision, accuracy, linearity, specificity & stability.
Pharmacokinetic (PK) & Bioequivalence Statistical Analysis
• Non-compartmental PK evaluations (AUC, Cmax, Tmax, t½).
• EMA-standard BE acceptance ranges: 90% CI between 80–125%.
• Scaled average BE for Highly Variable Drugs (HVDs).
• Sample-size and power calculations per EMA statistical guidelines.
📑 INFARMED- & EMA-Ready CTD Documentation
We prepare complete regulatory documentation for Portugal and EU submissions:
• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per ICH E3 & EMA format
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 1–5, supporting:
EU Generic Applications (Article 10)
Decentralized Procedure (DCP)
Mutual Recognition Procedure (MRP)
Centralized Procedure (CP)
✨ Why Choose BioEquiGlobal for Portugal?
• Fast & Reliable EU Research Environment: Portugal is an emerging EU hub for efficient and high-quality clinical BE studies.
• INFARMED + EMA-Aligned Expertise: Ensures BE data are accepted throughout Europe.
• High Regulatory & Scientific Standards: Fully GCP/GLP/GMP-compliant operations.
• Support for Complex Formulations: Including MR, HVDs, topicals, ophthalmic, inhalation & injectable products.
• End-to-End BE Study Support: From feasibility to PK/BE analysis and complete CTD dossier preparation.
🗺️ BA/BE Study Workflow for Portugal / EU Sponsors
Feasibility & Regulatory Strategy Review
(Reference product identification, EMA mapping, biowaiver assessment)Protocol Development & Ethical Approval (CEIC)
(EU-CTR compliant submission)Analytical Method Development & Validation
(ICH M10-compliant LC-MS/MS validation)Clinical Study Execution in Portugal
(Recruitment, dosing, sampling, and monitoring under EU-GCP)Bioanalysis & PK/BE Interpretation
(NCA, BE statistics including scaled BE for HVDs)CTD Documentation Preparation
(CSR, CDP, validation package & CTD Modules 1–5)
Who We Support in Portugal & Across Europe
• EU generic manufacturers
• Marketing Authorization Holders applying via DCP, MRP & CP
• CROs outsourcing BE or analytical work
• R&D teams reformulating EU-approved medicines
• International pharma entering the Portuguese/EU markets
• Biotech & specialty pharma organizations