🇧🇬 Bioavailability & Bioequivalence (BA/BE) Studies Services for Bulgaria
BDA (Bulgarian Drug Agency)–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 requirements of Bulgaria’s Bulgarian Drug Agency (BDA).
All studies follow BDA guidelines, EMA/EU regulations, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for Bulgarian national submissions and broader EU-wide approvals.
💊 Core Services for Bulgaria (BDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: EMA-approved single-dose & multiple-dose BA/BE designs (crossover and parallel).
• Volunteer Selection: Healthy volunteers or patient cohorts depending on indication.
• Ethics Approval: Required from a Bulgarian Research Ethics Committee (REC) accredited under national law.
• Protocol Development: Prepared in accordance with ICH E6 (R2) GCP, EMA BE Guidelines, and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration, product variations, and pharmaceutical equivalence evaluations.
• Dissolution Media: EU pharmacopeial & biorelevant media accepted by BDA.
• Similarity Factor: f2 similarity factor for dissolution curve comparison.
• Evaluation Approaches: EMA-recognized model-independent (f1, f2) and model-dependent approaches.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared as per EMA, WHO TRS, and ICH Q6A requirements.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Supports biowaiver justification and regulatory strategy optimization.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV platforms.
• Validation: Conducted according to ICH M10, WHO TRS, and BDA-recognized standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical dosage forms.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• BE Statistics: Conducted using EMA/ICH harmonized BE requirements accepted by BDA.
• Sample Size & Power: Scientifically calculated to ensure BE statistical reliability.
📑 Bulgaria BDA–Ready Regulatory Documentation
We prepare fully compliant regulatory documents for Bulgarian and EU submissions, including:
• Clinical Study Protocol (BDA/EU-compliant)
• Informed Consent Forms (ICF) meeting Bulgarian ethical standards
• 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 BDA submissions
✨ Why Choose BioEquiGlobal for the Bulgarian & EU Market?
• Regulatory Expertise: Deep understanding of Bulgarian Drug Agency and EMA regulatory expectations.
• International Quality Compliance: GCP, GLP, WHO TRS, and ICH adherence with robust internal quality systems.
• Advanced Facilities: Accredited clinical units and modern analytical laboratories (including NABL-certified labs).
• Global Regulatory Reach: CTD dossiers prepared for BDA, EMA, and international regulators (FDA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Bulgaria
Feasibility & Gap Assessment: Evaluation of EMA-recognized reference products, dissolution demands, and biowaiver eligibility.
Protocol Development: Drafting BDA/EMA-compliant BA/BE protocols and securing REC approval.
Analytical Method Development: LC-MS/MS validation per ICH M10 & WHO TRS.
Clinical Execution: GCP-monitored volunteer recruitment, dosing, sampling, and safety surveillance.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and EU-standard BE statistics.
Documentation & Submission: Preparation of BDA-ready CSR, dissolution reports, validation documents, and CTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Bulgaria and the EU market
• CROs requiring BA/BE outsourcing or advanced analytical services
• Regulatory teams needing BDA/EMA-compliant CTD dossiers