🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Chennai
CDSCO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for formulation companies, CROs, biotech units, and R&D centres based in Chennai, one of India’s most advanced pharmaceutical & clinical research hubs.
All studies comply with:
CDSCO (Central Drugs Standard Control Organization)
New Drugs & Clinical Trials Rules (NDCTR), 2019
ICMR Ethical Guidelines
ICH GCP & WHO TRS
GLP for analytical validations
We support submissions to CDSCO/DCGI, as well as export regulatory markets including USFDA, EMA, MHRA, TGA, Health Canada, and others.
💊 Core BA/BE Services for Chennai-Based Pharma & CROs
Clinical BA/BE Studies (Human)
• FDA/EMA-aligned single-dose & multiple-dose BE studies (crossover/parallel).
• Healthy volunteer studies and patient-centric studies depending on therapeutic class.
• Ethics review through CDSCO-registered IECs in Chennai.
• Protocols developed according to ICH E6 (R2), WHO TRS & CDSCO guidance.
Comparative Dissolution Profiling (CDP)
• Mandatory for Form 44 submissions, FDC approvals, and formulation modifications.
• Testing in pharmacopoeial (IP/USP) and biorelevant media (FaSSIF/FeSSIF).
• f2 similarity factor for profile comparison.
• Model-dependent and model-independent approaches.
IVIVC & Biowaiver Support
• BCS-based biowaiver justification per CDSCO, ICH Q6A, and WHO TRS.
• Level A/B/C IVIVC modeling for in vitro–in vivo predictability.
• Dissolution–PK correlation for formulation optimization.
Analytical Method Development & Validation
• LC-MS/MS, HPLC-UV, and stability-indicating methods.
• Bioanalytical method validation per ICH M10 & CDSCO standards.
• Stability studies for API & finished dosage forms.
Pharmacokinetic (PK) & Statistical BE Analysis
• Non-compartmental analysis (NCA) using validated platforms.
• BE evaluation via 90% CI acceptance range.
• Sample-size & power calculations based on intra-subject variability.
📑 CDSCO-Compliant Documentation for Chennai Submissions
We prepare full documentation required for DCGI submissions:
• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) — as per CDSCO & ICH E3 structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) applicable to Form 44 filings
✨ Why Choose BioEquiGlobal for Chennai?
• Strong Presence in Southern India’s Pharma Corridor: Chennai, Hosur, and Sriperumbudur clusters supported effectively.
• Regulatory Expertise: Depth of experience in NDCTR & CDSCO-compliant BE studies and dissolution requirements.
• Advanced R&D Infrastructure: NABL-certified analytical labs and accredited clinical units accessible nearby.
• Export-Ready Dossier Development: ANDA, CTD, eCTD preparation for global regulatory agencies.
• End-to-End Support: From dissolution development to regulatory filing.
🗺️ BA/BE Study Workflow for Chennai Sponsors
Feasibility & Regulatory Assessment
(Reference product identification, CDSCO gap review, biowaiver evaluation)Protocol Design & IEC Approval
(Ethics board approval through Chennai-based IECs)Analytical Method Development & Validation
(LC-MS/MS method development aligned with ICH M10)Clinical Study Execution
(GCP-compliant dosing, sampling, oversight, safety monitoring)Bioanalysis & PK/BE Evaluation
(PK modeling, QC verification, BE statistics)Documentation & Submission
(CSR, CDP report, validation package & CTD modules)
Who We Support in Chennai
• Pharmaceutical manufacturers (R&D & commercial)
• Biotech companies & innovation labs
• CROs & clinical trial units
• Export-oriented formulation companies
• Start-ups entering regulated markets