🇲🇩 Bioavailability & Bioequivalence (BA/BE) Studies Services for Moldova
AMDM–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory standards of the Medicines and Medical Devices Agency of Moldova (AMDM).
All studies are conducted in compliance with AMDM guidelines, EU/EMA regulations, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for pharmaceutical submissions in Moldova and across Europe.
💊 Core Services for Moldova (AMDM) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: EMA-recognized single-dose & multiple-dose crossover or parallel BE study designs.
• Volunteer Selection: Healthy volunteers or patient populations as required by therapeutic class.
• Ethics Approval: Mandatory approval from a Moldovan Research Ethics Committee (REC)/IRB.
• Protocol Development: Prepared according to ICH E6 (R2) GCP, EMA BE Guidelines, and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic registration, formulation modifications, and quality equivalence.
• Dissolution Media: Pharmacopeial & biorelevant media accepted by AMDM and EMA.
• Similarity Factor: f2 similarity factor for dissolution comparison.
• Evaluation Approaches: Model-independent (f1, f2) and EMA-approved model-dependent dissolution models.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared per WHO TRS, EMA/ICH guidance, and AMDM-compatible regulatory expectations.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Ensures regulatory justification for biowaivers and optimized BE study approaches.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV for accurate bioanalysis.
• Validation: Per ICH M10, WHO TRS, and EMA validation guidelines recognized by AMDM.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical formulations.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• BE Statistics: Conducted according to EMA/ICH harmonized BE standards accepted by AMDM.
• Sample Size & Power: Scientifically calculated for robust BE conclusions.
📑 Moldova AMDM–Ready Regulatory Documentation
We prepare comprehensive, Moldova-specific regulatory dossiers, including:
• Clinical Study Protocol (Moldova/EU-compliant)
• Informed Consent Forms (ICF) meeting Moldovan ethical norms
• Investigator Brochure
• Clinical Study Report (CSR) per EMA/ICH structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• EU CTD Modules (1–5) tailored for AMDM submissions
✨ Why Choose BioEquiGlobal for the Moldovan & EU Market?
• Expertise in AMDM & EMA Requirements: Ensures regulatory-ready BA/BE protocols, PK reports, dissolution studies, and CTD dossiers.
• International Quality Compliance: GCP, GLP, WHO TRS, and ICH adherence supported by strict QA processes.
• Advanced Infrastructure: Accredited clinical research units and high-precision analytical laboratories (including NABL-certified facilities).
• Global Submission Capability: CTD preparation for Moldova and worldwide agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Moldova
Feasibility & Gap Assessment: Analysis of EMA-approved reference products, dissolution requirements, and biowaiver feasibility.
Protocol Development: Drafting AMDM/EMA-compliant BA/BE protocols and obtaining ethical approval.
Analytical Method Development: LC-MS/MS method development & validation per ICH M10 & WHO TRS.
Clinical Study Execution: GCP-supervised recruitment, dosing, sampling, and medical monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and EMA-standard BE statistics.
Documentation & Submission: Preparation of AMDM-ready CSR, dissolution reports, validation documentation, and CTD Modules 1–5.
Who We Support
• Pharmaceutical manufacturers targeting Moldova or regional EU markets
• CROs needing BA/BE outsourcing or analytical expertise
• Regulatory teams requiring AMDM-compliant CTD dossiers