🇪🇸 Bioavailability & Bioequivalence (BA/BE) Studies Services for Spain
AEMPS–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory standards of the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).
All studies follow AEMPS guidelines, EMA/EU regulations, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for Spain’s national submissions and EU-wide approvals.
đź’Š Core Services for Spain (AEMPS) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: EMA-approved single-dose & multiple-dose BE designs (crossover or parallel).
• Volunteer Selection: Healthy volunteers or special patient populations based on therapeutic indication.
• Ethics Approval: Required from a Spanish Comité de Ética de la Investigación con medicamentos (CEIm).
• Protocol Development: Prepared according to ICH E6 (R2) GCP, EMA BE Guidelines, and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug applications, formulation changes, and equivalence demonstrations.
• Dissolution Media: EU pharmacopeial and biorelevant media recognized by AEMPS.
• Similarity Factor: f2 similarity factor to compare dissolution profiles.
• Evaluation Models: EMA-compliant model-independent (f1, f2) and model-dependent dissolution analyses.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to EMA, WHO TRS, and ICH Q6A guidelines.
• IVIVC Modeling: Level A, B, and C in vitro–in vivo correlation models.
• Predictive PK Modeling: Supports biowaiver justification and optimized BE strategies.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV systems.
• Validation: Per ICH M10, WHO TRS, and AEMPS/EMA bioanalytical validation requirements.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA).
• BE Statistics: Performed using EMA/ICH harmonized standards.
• Sample Size & Power: Scientifically determined to ensure BE confidence.
📑 Spain AEMPS–Ready Regulatory Documentation
We prepare complete documentation suitable for AEMPS and EU submissions, including:
• Clinical Study Protocol (AEMPS/EU-compliant)
• Informed Consent Forms (ICF) per Spanish CEIm standards
• Investigator Brochure
• Clinical Study Report (CSR) per EMA/ICH structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• EU CTD Modules (1–5) formatted for AEMPS submissions
✨ Why Choose BioEquiGlobal for the Spanish & EU Market?
• Local Regulatory Expertise: Deep knowledge of AEMPS and EMA regulatory frameworks.
• International Standards Compliance: GCP, GLP, WHO TRS, and ICH adherence supported by robust QA systems.
• Advanced Clinical & Analytical Facilities: Accredited clinical units and modern analytical labs (including NABL-certified facilities).
• Global Submission Capability: CTD preparation for AEMPS, EMA, FDA, MHRA, TGA, GCC, SAHPRA, and others.
🗺️ BA/BE Study Workflow for Spain
Feasibility & Gap Assessment: Evaluation of reference products, EMA dissolution requirements, and biowaiver options.
Protocol Development: Drafting AEMPS/EMA-compliant BA/BE protocols and securing CEIm approval.
Analytical Method Development: LC-MS/MS method design and validation per ICH M10 & EMA guidelines.
Clinical Study Execution: GCP-supervised subject recruitment, dosing, PK sampling, and safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and EMA-standard BE statistics.
Documentation & Submission: Preparation of AEMPS-ready CSR, dissolution reports, validation documentation, and CTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Spain and the wider EU market
• CROs requiring BA/BE outsourcing or analytical support
• Regulatory teams needing AEMPS/EMA-compliant CTD dossiers