🇷🇴 Bioavailability & Bioequivalence (BA/BE) Studies Services for Romania
ANMDMR–Compliant BA/BE & Comparative Dissolution Profiling — 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 requirements of the National Agency for Medicines and Medical Devices of Romania (ANMDMR).
All studies strictly follow ANMDMR guidelines, EMA/EU regulations, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for national submissions and EU-wide approvals.
💊 Core Services for Romania (ANMDMR) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: EMA-accepted single-dose & multiple-dose crossover or parallel BE studies.
• Volunteer Selection: Healthy volunteers or special populations depending on therapeutic indication.
• Ethics Approval: Required from a Romanian Research Ethics Committee (REC) accredited by national law.
• Protocol Development: Prepared following ICH E6 (R2) GCP, EMA BE Guidelines, and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration, formulation changes, and quality equivalence tests.
• Dissolution Media: EU pharmacopeial and biorelevant media recognized by ANMDMR.
• Similarity Factor: f2 similarity factor for dissolution curve comparison.
• Evaluation Models: Includes model-independent (f1, f2) and model-dependent EMA-approved dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared under EMA, WHO TRS, and ICH Q6A guidelines.
• IVIVC Modeling: Level A, B, and C models used for predicting in vivo drug behavior.
• Predictive PK Modeling: Supports biowaiver justification and regulatory strategy optimization.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV platforms.
• Validation: According to ICH M10, WHO TRS, and EMA bioanalytical validation standards.
• Stability-Indicating Methods: Developed for APIs and finished dosage forms.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA).
• BE Statistics: Conducted using EMA/ICH harmonized standards accepted by ANMDMR.
• Sample Size & Power: Determined scientifically for reliable BE outcomes.
📑 Romania ANMDMR–Ready Regulatory Documentation
We prepare full Romania/EU-compliant documentation, including:
• Clinical Study Protocol (Romania/EU-compliant)
• Informed Consent Forms (ICF) meeting Romanian ethical 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 ANMDMR submissions
✨ Why Choose BioEquiGlobal for the Romanian & EU Market?
• Deep ANMDMR & EMA Regulatory Knowledge: Full alignment with Romanian and EU pharmaceutical requirements.
• Strict Global Quality Standards: GCP, GLP, WHO TRS, and ICH compliance with robust QA systems.
• Modern Clinical & Analytical Infrastructure: Accredited clinical units and high-performance analytical labs (including NABL-certified facilities).
• International Regulatory Support: CTD preparation for Romanian submissions and global authorities (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Romania
Feasibility & Gap Assessment: Review of reference products, EMA/EU dissolution expectations, and biowaiver potential.
Protocol Development: Drafting ANMDMR/EMA-compliant BA/BE protocols and obtaining REC approval.
Analytical Method Development: LC-MS/MS validation per ICH M10 & EMA guidelines.
Clinical Study Execution: GCP-supervised recruitment, dosing, sampling, and medical safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE evaluation.
Documentation & Submission: Preparation of ANMDMR-ready CSR, dissolution reports, validation documents, and CTD Modules 1–5.
Who We Support
• Pharmaceutical manufacturers targeting Romania or the EU market
• CROs requiring BE/analytical outsourcing
• Regulatory teams needing ANMDMR/EMA-compliant CTD dossiers