🇫🇮 Bioavailability & Bioequivalence (BA/BE) Studies Services for Finland
Fimea & EMA-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers complete Bioavailability (BA) and Bioequivalence (BE) studies, alongside Comparative Dissolution Profiling, specifically tailored for pharmaceutical companies seeking regulatory approval in Finland and across the European Union (EU).
All studies and documentation comply with:
Fimea (Finnish Medicines Agency) clinical trial & bioequivalence 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 & EU-GLP standards
EU-GMP (Annex 13) for clinical supplies
European Pharmacopoeia (Ph. Eur.)
Finland is known for its world-class healthcare environment, strong regulatory governance, and high data-quality standards—making it an excellent location for BA/BE studies intended for EU-wide use.
💊 Core BA/BE Services for Finland & EMA Submissions
Clinical BA/BE Studies (Human)
• Conducted in alignment with Fimea regulations, EMA BE Guidelines, and EU-GCP.
• Study types include single-dose, multiple-dose, crossover & parallel BE designs.
• Healthy volunteer or patient-based studies as required for therapeutic categories.
• Ethical approval through Finnish Ethics Committees under EU-CTR 536/2014.
• Protocols compliant with ICH E6 (R2), EMA BE rules & Ph. Eur. expectations.
Comparative Dissolution Profiling (CDP)
• Required for EU generic submissions under Article 10 of Directive 2001/83/EC.
• Dissolution testing using Ph. Eur., USP, and biorelevant media (FaSSIF/FeSSIF).
• f2 similarity factor calculations for profile equivalence.
• Model-based & model-independent dissolution comparisons.
IVIVC & Biowaiver Support
• EMA & ICH Q6A-compliant BCS-based biowaiver preparation.
• IVIVC modeling (Level A/B/C) for predictive PK–dissolution correlation.
• Waiver support for eligible BCS Class I & III medicines.
Analytical Method Development & Validation
• LC-MS/MS & HPLC-UV analytical methods validated under ICH M10.
• Full validation: accuracy, precision, sensitivity, selectivity, stability & linearity.
• Stability-indicating methods for both APIs and finished dosage forms.
Pharmacokinetic (PK) & BE Statistical Analysis
• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• EMA BE acceptance criteria: 90% CI within 80.00–125.00%.
• Scaled average BE options for Highly Variable Drugs (HVDs).
• Statistical power & sample-size optimization per EMA guidelines.
📑 Fimea- & EMA-Ready CTD Documentation
BioEquiGlobal prepares complete EU-ready documentation sets, including:
• 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 (CDP) Report
• CTD Modules 1–5 for:
EU Generic Applications (Article 10)
Decentralized Procedure (DCP)
Mutual Recognition Procedure (MRP)
Centralized Procedure (CP)
✨ Why Choose BioEquiGlobal for Finland?
• High-Quality Research Environment: Finland offers exceptional clinical trial infrastructure and regulatory transparency.
• EMA-Centric Design: All studies match EMA requirements, ensuring seamless pan-EU submissions.
• Rigorous Quality Control: GCP-, GLP-, and GMP-based operations meet global regulatory standards.
• Efficient EU Integration: BE data generated for Finland supports approvals across all EU/EEA markets.
• End-to-End Support: From feasibility and protocol design to PK/BE evaluation and final CTD dossier preparation.
🗺️ BA/BE Study Workflow for Finland / EU Sponsors
Feasibility & EMA/Fimea Regulatory Assessment
(Reference product evaluation, EMA guideline mapping, biowaiver feasibility)Protocol Development & Ethics Approval
(Submission to Finnish Ethics Committees under EU-CTR)Analytical Method Development & Validation
(ICH M10-compliant LC-MS/MS validation and stability testing)Clinical Study Execution in Finland
(Volunteer recruitment, dosing, PK sampling, GCP-compliant monitoring)Bioanalysis & PK/BE Evaluation
(NCA, statistical BE evaluation, HVD & scaled BE support)Final Documentation & CTD Submission
(CSR, Comparative Dissolution Profile, validation reports & CTD Modules)
Who We Support in Finland & Across Europe
• Generic pharmaceutical manufacturers
• EU MAH applicants using DCP/MRP/CP pathways
• CROs outsourcing BA/BE, PK, or bioanalytical work
• R&D units reformulating EU-authorized medicines
• Export-oriented pharmaceutical companies targeting EU markets
• Specialty pharma & biotech innovators