🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Mumbai
CDSCO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for pharmaceutical companies, CROs, formulation development units, and biotech organizations operating in Mumbai, India’s premier pharma, biotech, and regulatory hub.
All studies adhere to:
CDSCO (Central Drugs Standard Control Organization)
New Drugs & Clinical Trials Rules (NDCTR), 2019
ICH GCP & WHO TRS
GLP standards
ICMR Ethical Guidelines
We support submissions for CDSCO/DCGI, and global markets — USFDA, EMA, MHRA, TGA, Health Canada, SAHPRA, GCC, and more.
💊 Core BA/BE Services for Mumbai & Navi Mumbai Pharma Ecosystem
Clinical BA/BE Studies (Human)
• Single-dose & multiple-dose BE studies (crossover & parallel).
• Healthy volunteer & patient-specific studies depending on therapeutic area.
• Ethics approval through CDSCO-registered IECs in Mumbai/Navi Mumbai.
• BE protocol development aligned with ICH E6 (R2), WHO TRS & CDSCO guidelines.
Comparative Dissolution Profiling (CDP)
• Required for Form 44 submissions, FDC approvals, and generic drug development.
• Pharmacopoeial (IP/USP/EP) & biorelevant dissolution media.
• f2 similarity factor for dissolution comparison.
• Model-independent & model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-based biowaiver preparation as per CDSCO, ICH Q6A, and WHO TRS.
• Level A/B/C IVIVC models for predictive in vitro–in vivo performance.
• PK modeling to strengthen regulatory justification.
Analytical Method Development & Validation
• LC-MS/MS and HPLC-UV analytical platforms.
• Validation according to ICH M10 and CDSCO bioanalytical requirements.
• Stability-indicating method development for APIs & formulations.
Pharmacokinetic (PK) & BE Statistical Evaluation
• Non-compartmental PK analysis (NCA).
• BE acceptance evaluated using standard 90% CI statistical limits.
• Power & sample-size calculations for optimal study outcomes.
📑 CDSCO-Ready Documentation for Mumbai Sponsors
We prepare complete regulatory documentation essential for Indian and global submissions:
• Clinical Study Protocol
• Informed Consent Form (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, ANDA, or international submissions
✨ Why Choose BioEquiGlobal for Mumbai?
• Indian Pharma Headquarters Hub: Mumbai hosts HQs of major pharmaceutical companies, enabling fast coordination and streamlined study management.
• CRO & Clinical Research Capital: Access to world-class hospitals, CROs, and bioanalytical labs.
• Regulatory Connectivity: Proximity to FDA Bhavan (CDSCO West Zone) ensures efficient communication.
• Cutting-Edge Infrastructure: Access to NABL-certified labs and accredited clinical units.
• Global Regulatory Expertise: Skilled in preparing CTDs and eCTDs for regulated markets.
🗺️ BA/BE Study Workflow for Mumbai-Based Sponsors
Feasibility & Regulatory Assessment
(Reference product availability, CDSCO mapping, biowaiver evaluation)Protocol Development & IEC Approval
(Ethics submissions through Mumbai-based IECs)Analytical Method Development & Validation
(Assay development using LC-MS/MS per ICH M10)Clinical Execution of BA/BE Studies
(GCP-compliant recruitment, dosing, sampling & safety monitoring)Bioanalysis & PK/BE Interpretation
(PK modeling, QC checks & BE statistical analysis)Final Documentation & Submission
(CSR, CDP report, validation package & CTD-ready modules)
Who We Support in Mumbai
• Generic & specialty pharmaceutical companies
• CROs & clinical research organizations
• Formulation development & R&D centers
• Bioanalytical laboratories
• Export-focused manufacturers
• Start-ups entering global regulated markets