🇧🇩 Bioavailability & Bioequivalence (BA/BE) Studies Services for Bangladesh
DGDA-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a dedicated scientific brand of Zoesoe Exports Pvt Ltd, provides complete BA/BE study services and Comparative Dissolution Profiling tailored for Bangladesh regulatory requirements, as mandated by the Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare.
Our studies strictly follow GCP, GLP, ICH, WHO TRS, ASEAN/ICH guidelines, and DGDA requirements to support pharmaceutical companies in achieving approvals for both Bangladesh domestic marketing authorization and export submissions.
💊 Our Core Services for Bangladesh Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Design: Single-dose/multiple-dose studies using crossover or parallel designs in accordance with DGDA BA/BE guidance.
• Volunteer Selection: Healthy volunteer participation and patient studies when required by protocol and DGDA approval.
• Ethics Approval: Clearance from an Institutional Ethics Committee (IEC) registered/recognized under Bangladesh regulatory norms.
• Protocol Development: DGDA-aligned protocols incorporating ICH E6 (R2) GCP, WHO TRS, and international BA/BE standards.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Needed for generic drug registration and post-approval variation submissions under DGDA guidelines.
• Media: Biorelevant and standard dissolution media per pharmacopeial and DGDA expectations.
• Analysis: Calculation of f2 similarity factor for required comparison between test and reference profiles.
• Comparison Methods: Model-independent (f1, f2) and model-dependent dissolution evaluation.
IVIVC & Biowaiver Support
• Biowaiver Support: Preparation of BCS-based biowaiver justification as per DGDA, WHO TRS, and ICH Q6A guidance.
• IVIVC Modeling: Development of Level A, B, and C IVIVC correlations.
• Evaluation: Predictive dissolution–pharmacokinetic modeling for regulatory acceptance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV-based methods suitable for Bangladesh BA/BE submissions.
• Validation: Bioanalytical validation according to ICH M10, WHO, and DGDA bioanalytical requirements.
• Stability Studies: Stability-indicating method development for API and formulations.
Pharmacokinetic (PK) Analysis
• PK Type: Non-compartmental PK analysis (NCA).
• Statistical Analysis: DGDA/ICH-aligned statistical evaluation to determine bioequivalence.
• Design Support: Sample-size calculation and power analysis based on DGDA guidelines.
📑 DGDA-Ready Regulatory Documentation
We prepare complete documentation tailored for submission to the DGDA (Bangladesh):
• Clinical Study Protocol (DGDA-aligned)
• Informed Consent Forms (ICF) as per Bangladesh GCP requirements
• Investigator Brochure
• Clinical Study Report (CSR) following DGDA & ICH structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD modules formatted for DGDA drug registration applications
✨ Why Choose BioEquiGlobal for the Bangladesh Market?
• DGDA-Focused Designs: Protocols aligned with Bangladesh BA/BE guidelines, WHO TRS recommendations, and ASEAN/ICH harmonized requirements.
• Quality Assurance: SOP-driven operations with internal QA audits, adhering to recognized global GCP/GLP standards.
• Advanced Infrastructure: Accredited BA/BE clinical units and analytical laboratories (including NABL-certified labs where applicable).
• Global Dossier Capability: Support for DGDA, US FDA, EMA, GCC, TGA, MHRA, and other international regulatory markets.
🗺️ Our BA/BE Study Workflow for Bangladesh
Feasibility & DGDA Gap Assessment: Reference product evaluation, BCS classification, and eligibility for biowaiver as per DGDA/WHO guidelines.
Protocol Development & Strategy: DGDA-aligned BA/BE protocol creation and submission to Institutional Ethics Committee for approval.
Analytical Method Development: LC-MS/MS method development with validation following ICH M10 and DGDA requirements.
Clinical Study Execution: Controlled volunteer recruitment, dosing, sampling, and monitoring in compliance with GCP.
Bioanalysis & PK Evaluation: Full bioanalytical phase, QC checks, PK modeling, and BE statistics generation.
Documentation & Submission: Preparation of DGDA-compliant CSR, analytical reports, dissolution reports, and a complete CTD/ACTD-ready dossier.
Who We Support
• Bangladesh pharmaceutical manufacturers seeking DGDA registration and international export approvals
• CROs needing specialized BA/BE execution or analytical outsourcing
• Regulatory teams requiring DGDA-compliant CTD/ACTD documentation packages