🇬🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Georgia
SRAMA–Compliant BA/BE & Comparative Dissolution Profiling Services — 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 Georgia’s State Regulation Agency for Medical Activities (SRAMA).
All studies strictly adhere to SRAMA guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for Georgian pharmaceutical registration and international submissions.
💊 Core Services for Georgia (SRAMA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BA/BE studies using crossover or parallel models recognized by SRAMA.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic requirements.
• Ethics Approval: Required from a Georgian Research Ethics Committee (REC)/IRB.
• Protocol Development: SRAMA-aligned protocols following ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for generic product submission, formulation changes, and equivalence justification.
• Dissolution Media: Pharmacopeial and biorelevant media accepted by SRAMA.
• Similarity Factor: f2 similarity factor for dissolution profile comparison.
• Evaluation Approaches: Both model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared per WHO TRS, ICH Q6A, and SRAMA-compatible guidelines.
• IVIVC Modeling: Level A, B, and C in vitro–in vivo correlation models.
• Predictive PK Modeling: Supports regulatory justification for biowaiver acceptance.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV analytical systems.
• Validation: In accordance with ICH M10, WHO TRS, and standards recognized by SRAMA.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Conducted using ICH/WHO harmonized BE criteria accepted by SRAMA.
• Sample Size & Power: Scientifically calculated to ensure reliable BE conclusions.
📑 Georgia SRAMA–Ready Regulatory Documentation
We prepare full regulatory documentation tailored for submission to the State Regulation Agency for Medical Activities, including:
• Clinical Study Protocol (Georgia-compliant)
• Informed Consent Forms (ICF) aligned with national ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules (1–5) formatted for SRAMA submissions
✨ Why Choose BioEquiGlobal for the Georgian Market?
• Local Regulatory Alignment: Protocols, analytical validations, PK reports, and CTD dossiers tailored to SRAMA guidelines.
• Global Quality Standards: Full compliance with GCP, GLP, ICH, and WHO TRS backed by strict QA systems.
• Advanced Analytical & Clinical Infrastructure: Modern laboratories (including NABL-certified facilities) and accredited clinical units.
• Wide Submission Capability: CTDs prepared for SRAMA as well as global authorities (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Georgia
Feasibility & Gap Assessment: Evaluation of reference products, dissolution requirements, and biowaiver eligibility.
Protocol Development: Drafting SRAMA-compliant BA/BE protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method development & validation as per ICH M10 & WHO TRS.
Clinical Study Execution: GCP-supervised recruitment, dosing, sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE assessment.
Documentation & Submission: Preparation of Georgia-ready CSR, dissolution reports, validation documentation, and CTD modules.
Who We Support
• Georgian pharmaceutical manufacturers seeking SRAMA approval
• CROs requiring BA/BE outsourcing or analytical services
• Regulatory teams needing SRAMA-compliant CTD dossiers