🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Thane
CDSCO-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 to support pharmaceutical organizations located in Thane, a major pharma, chemical, and biotech hub adjoining Mumbai.
Thane’s industrial belt—including Wagle Estate, Rabale, Airoli, Ambernath, Badlapur, Taloja, Turbhe, and Dombivli—houses numerous formulation and active pharmaceutical manufacturers requiring regulatory-compliant BA/BE services.
All studies follow:
CDSCO (Central Drugs Standard Control Organization)
New Drugs & Clinical Trials Rules (NDCTR), 2019
ICH GCP & WHO TRS
GLP standards
ICMR Ethical Guidelines
We support regulatory submissions to CDSCO/DCGI, as well as international agencies such as USFDA, EMA, MHRA, TGA, Health Canada, and others.
💊 Core BA/BE Services for Thane’s Pharma, Biotech & CRO Ecosystem
Clinical BA/BE Studies (Human)
• Single-dose & multiple-dose BE studies (crossover & parallel designs).
• Healthy volunteer studies or patient-based trials as applicable.
• IEC approval via CDSCO-registered Ethics Committees in Mumbai/Thane/Navi Mumbai.
• Protocols aligned with ICH E6 (R2), WHO TRS & CDSCO requirements.
Comparative Dissolution Profiling (CDP)
• Required for Form 44 submissions, FDC approvals, and regulatory variations.
• Dissolution testing conducted in IP/USP/EP & biorelevant media.
• f2 similarity factor evaluation.
• Model-independent & model-dependent dissolution analysis.
IVIVC & Biowaiver Support
• BCS-based biowaiver development per CDSCO, WHO TRS, and ICH Q6A.
• Level A/B/C IVIVC modeling to correlate dissolution with PK.
• Supports waiver of in vivo BE studies where scientifically justified.
Analytical Method Development & Validation
• LC-MS/MS & HPLC-UV method development and validation.
• Validation as per ICH M10 and CDSCO bioanalytical norms.
• Stability-indicating method development for APIs & formulations.
Pharmacokinetic (PK) & BE Statistical Analysis
• Non-compartmental PK analysis (NCA).
• BE evaluation using 90% CI BE acceptance criteria.
• Sample-size & power calculations for optimized study design.
📑 CDSCO-Compliant Documentation for Thane Submissions
We provide complete regulatory documentation, including:
• Clinical Study Protocol
• Informed Consent Forms (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) compliant with CDSCO & ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) for Form 44 & global filings
✨ Why Choose BioEquiGlobal for Thane?
• Strategic Pharma & Chemical Manufacturing Zone: Thane is home to multiple formulation units, chemical intermediates, and contract manufacturers.
• Regulatory Advantage: Proximity to Mumbai’s CDSCO West Zone and major clinical trial centres.
• Robust Infrastructure: Access to NABL-accredited analytical labs and accredited clinical research units.
• Global Submission Expertise: Support for ANDA, CTD, eCTD, and global regulatory dossiers.
• End-to-End Partnership: From dissolution development to full BE execution and submission.
🗺️ BA/BE Study Workflow for Thane Sponsors
Feasibility & CDSCO Assessment
(Reference product selection, biowaiver feasibility, regulatory gap review)Protocol Development & IEC Approval
(Ethics submission via IECs in Thane/Mumbai/Navi Mumbai)Analytical Method Development & Validation
(LC-MS/MS assay validation per ICH M10)Clinical BA/BE Study Execution
(GCP-compliant recruitment, dosing, PK sampling & safety monitoring)Bioanalysis & PK/BE Evaluation
(PK modeling, QC checks, BE statistical analysis)Documentation & Submission
(CSR, CDP, validation reports & CTD modules)
Who We Support in Thane
• Pharmaceutical formulation manufacturers
• API & chemical intermediate producers expanding into formulations
• CROs & bioanalytical laboratories
• Biotech & specialty drug developers
• Export-focused pharmaceutical units
• Start-ups entering regulated markets