🇪🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Estonia
SAM (Ravimiamet)–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory expectations of Estonia’s State Agency of Medicines (SAM / Ravimiamet).
All studies strictly comply with SAM guidelines, EMA/European Union regulations, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for Estonia’s regulatory submissions and the broader EU market.
💊 Core Services for Estonia (SAM / Ravimiamet) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: EMA-accepted single-dose & multiple-dose BA/BE using crossover or parallel models.
• Volunteer Selection: Healthy volunteers or patient populations as required by the therapeutic class.
• Ethics Approval: Mandatory approval from an Estonian Research Ethics Committee (REC).
• Protocol Development: Prepared according to ICH E6 (R2) GCP, EMA BE Guidelines, and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for EU/Estonia generic submissions, variations, and quality equivalence.
• Dissolution Media: EU/EMA-recognized pharmacopeial and biorelevant media.
• Similarity Factor: f2 similarity factor calculated for dissolution profile comparison.
• Evaluation Methods: Model-independent (f1, f2) and EMA-accepted model-dependent approaches.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared per EMA guidelines, WHO TRS, and ICH Q6A.
• IVIVC Modeling: Level A, B, and C models for enhanced predictability.
• Predictive PK Modeling: Supports scientific justification for biowaivers and optimized BE strategies.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV systems.
• Validation: Per ICH M10, EMA bioanalytical validation standards, and WHO TRS.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA) aligned with EMA expectations.
• Statistical BE Evaluation: Conducted using EMA/ICH harmonized standards.
• Sample Size & Power: Scientifically calculated to meet EU statistical reliability requirements.
📑 Estonia SAM–Ready Regulatory Documentation
We prepare complete regulatory documentation designed for submission to the Estonian State Agency of Medicines, including:
• Clinical Study Protocol (Estonia/EU-compliant)
• Informed Consent Forms (ICF) aligned with Estonian ethical regulations
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & EMA structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• EU CTD Modules (1–5) formatted for SAM submission
✨ Why Choose BioEquiGlobal for the Estonian & EU Market?
• EU Regulatory Alignment: All protocols, datasets, and CTDs prepared according to EMA + SAM requirements.
• International Quality Standards: Full adherence to GCP, GLP, WHO TRS, and ICH guidelines, supported by robust QA systems.
• Advanced Analytical & Clinical Capability: Equipped with modern analytical labs (including NABL-certified facilities) and accredited clinical units.
• Wide Global Submission Expertise: CTD for Estonia, EMA markets, and international agencies (US FDA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Estonia
Feasibility & Gap Assessment: Review of EMA-listed reference products, dissolution expectations, and biowaiver options.
Protocol Development: Drafting SAM/EMA-compliant BA/BE protocols and overseeing REC approval.
Analytical Method Development: LC-MS/MS validation per ICH M10 & EMA guidelines.
Clinical Execution: GCP-monitored subject recruitment, dosing, sample collection, and safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and EU-standard BE statistics.
Documentation & Submission: Preparation of Estonia SAM–ready CSR, dissolution reports, validation documentation, and CTD modules (1–5).
Who We Support
• Pharmaceutical manufacturers seeking Estonia/SAM or EU-wide approval
• CROs requiring analytical or BE outsourcing
• Regulatory teams needing SAM/EMA-compliant CTD dossiers