🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Kolkata
CDSCO-Com
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 designed for pharmaceutical manufacturers, CROs, hospitals, and biotech/R&D centers operating in Kolkata, West Bengal.
All studies are conducted in accordance with:
CDSCO (Central Drugs Standard Control Organization)
New Drugs & Clinical Trials Rules (NDCTR), 2019
ICH GCP & WHO TRS
GLP standards
ICMR Ethical Guidelines
We support local submissions to CDSCO/DCGI and international submissions to USFDA, EMA, MHRA, TGA, Health Canada, and others.
💊 Core BA/BE Services for Kolkata’s Pharma & Research Ecosystem
Clinical BA/BE Studies (Human)
• Single-dose & multiple-dose BE studies (crossover/parallel).
• Healthy volunteer & patient-centric studies as per therapeutic need.
• IEC approval through CDSCO-registered ethics committees in Kolkata.
• Protocol design aligned with ICH E6 (R2), WHO TRS & CDSCO guidelines.
Comparative Dissolution Profiling (CDP)
• Required for generic drug development, Form 44 submissions, and FDC approvals.
• Pharmacopoeial (IP/USP/EP) & biorelevant media (FaSSIF/FeSSIF).
• f2 similarity factor for dissolution curve comparison.
• Model-independent & model-dependent dissolution analysis.
IVIVC & Biowaiver Support
• BCS-based biowaiver justification according to CDSCO, ICH Q6A, and WHO TRS.
• Level A/B/C IVIVC modeling for predictive correlation.
• PK-based modeling to support in vivo waiver requests.
Analytical Method Development & Validation
• LC-MS/MS and HPLC-UV method development & validation.
• Bioanalytical validation per ICH M10 and CDSCO expectations.
• Stability-indicating methods for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) & BE Statistical Evaluation
• Non-compartmental PK analysis (NCA).
• BE evaluation using standard 90% CI acceptance criteria.
• Sample-size & power calculation to ensure robust study outcomes.
📑 CDSCO-Compliant Documentation for Kolkata Submissions
We prepare complete documentation for regulatory submissions:
• Clinical Study Protocol
• Informed Consent Forms (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) as per CDSCO & ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) ready for Form 44 & global filings
✨ Why Choose BioEquiGlobal for Kolkata?
• Emerging Eastern India Pharma Hub: Supporting formulation units, R&D centers, CROs, and hospital-based research.
• Regulatory Excellence: Strong experience with CDSCO norms, NDCTR requirements, and global dossier standards.
• Infrastructure Access: NABL-accredited analytical facilities and clinical research units located across Eastern India.
• Global Market Support: Expertise in ANDA, CTD, eCTD documentation for regulated markets.
• End-to-End Service: From method development & dissolution to clinical execution & regulatory submission.
🗺️ BA/BE Study Workflow for Kolkata Sponsors
Feasibility & Regulatory Assessment
(Reference product evaluation, CDSCO gap assessment, biowaiver feasibility)Protocol Development & IEC Approval
(Ethics submissions to Kolkata-based IECs)Analytical Method Development & Validation
(LC-MS/MS per ICH M10 & CDSCO guidelines)Clinical Study Execution
(GCP-compliant volunteer recruitment, dosing, sampling & monitoring)Bioanalysis, PK & BE Evaluation
(PK modeling, QC checks, BE statistical assessment)Documentation & Submission
(CSR, CDP report, validation package & CTD modules)
Who We Support in Kolkata
• Generic drug manufacturers
• Formulation R&D and analytical labs
• CROs & clinical research units
• Hospital research centers
• Export-oriented pharma companies
• Start-ups entering regulated pharmaceutical markets