🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Faridabad
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 to support pharmaceutical companies, CROs, hospitals, and R&D centres located in Faridabad, a key industrial and biomedical hub within Delhi NCR.
All studies comply with:
CDSCO (Central Drugs Standard Control Organization)
New Drugs & Clinical Trials Rules (NDCTR), 2019
ICH GCP & WHO TRS
GLP, and ICMR Ethical Guidelines
We support regulatory submissions for CDSCO/DCGI as well as international authorities such as USFDA, EMA, MHRA, TGA, Health Canada, and others.
💊 Core BA/BE Services for Faridabad-Based Pharma & CROs
Clinical BA/BE Studies (Human)
• Single-dose & multiple-dose BE studies (crossover or parallel).
• Healthy volunteer & patient-based studies depending on product type.
• Ethics approval through CDSCO-registered Institutional Ethics Committees (IECs) in Faridabad/Delhi NCR.
• Protocol design aligned with ICH E6 (R2), WHO TRS & CDSCO guidance documents.
Comparative Dissolution Profiling (CDP)
• Required for Form 44 filings, generic approvals, and formulation modifications.
• Pharmacopoeial (IP/USP/EP) & biorelevant media used for dissolution studies.
• f2 similarity factor analysis for profile comparison.
• Model-dependent and model-independent dissolution evaluations.
IVIVC & Biowaiver Support
• BCS-based biowaiver preparation per CDSCO, ICH Q6A, and WHO TRS.
• Level A/B/C IVIVC modeling for in vitro–in vivo predictivity.
• Supports waiver of in vivo BE studies where applicable.
Analytical Method Development & Validation
• LC-MS/MS & HPLC-UV-based analytical platforms.
• Validation performed according to ICH M10 and CDSCO bioanalytical requirements.
• Stability-indicating methods for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) & Statistical Analysis
• Non-compartmental PK analysis (NCA).
• BE acceptance evaluated using 90% CI criteria.
• Sample-size & power estimation based on variability and CDSCO guidance.
📑 CDSCO-Ready Documentation for Faridabad Submissions
We prepare full regulatory documentation, including:
• Clinical Study Protocol
• Informed Consent Forms (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per CDSCO & ICH E3 requirements
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) for Form 44/Indian drug approvals
✨ Why Choose BioEquiGlobal for Faridabad?
• Industrial & Pharma Hub: Faridabad’s growing R&D and formulation manufacturing sector is supported with end-to-end regulatory and BE services.
• Proximity to Delhi & CDSCO HQ: Faster coordination, document review, and regulatory interactions.
• Advanced Infrastructure: Access to NABL-certified labs and accredited clinical BA/BE centres in Delhi NCR.
• Global Regulatory Readiness: ANDA, CTD, and eCTD dossier preparation for worldwide agencies.
• Customizable Support: Ideal for companies scaling from manufacturing to regulated-market submissions.
🗺️ BA/BE Study Workflow for Faridabad Sponsors
Feasibility & Regulatory Assessment
(Reference selection, CDSCO gap mapping, biowaiver evaluation)Protocol Development & IEC Approval
(Ethics submission to NCR-based IECs)Analytical Method Development & Validation
(LC-MS/MS validation per ICH M10)Clinical Study Execution
(GCP-compliant recruitment, dosing, sampling & monitoring)Bioanalysis & PK/BE Evaluation
(PK modeling, QC checks & BE statistics)Documentation & Submission
(CSR, CDP, validation packages & CTD-ready modules)
Who We Support in Faridabad
• Formulation & generic drug manufacturers
• CROs, hospitals & clinical research units
• Bioanalytical laboratories
• R&D-focused pharma companies
• Export-oriented manufacturers targeting regulated markets