🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Delhi NCR
CDSCO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers end-to-end Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for pharma companies, CROs, and research institutions located in Delhi NCR, India’s leading regulatory and clinical research hub.
All studies adhere to:
CDSCO (Central Drugs Standard Control Organization)
New Drugs & Clinical Trials Rules, 2019
ICMR Ethical Guidelines
ICH GCP & GLP
WHO Technical Report Series (TRS)
We support regulatory submissions for CDSCO/DCGI, and international markets including USFDA, EMA, MHRA, TGA, Health Canada, and more.
💊 Core BA/BE Services for Delhi NCR Pharma & CRO Ecosystem
Clinical BA/BE Studies (Human)
• Single-dose & multiple-dose BE studies (crossover/parallel).
• Volunteer studies (healthy or patient-based) under strict GCP oversight.
• IEC approval from CDSCO-registered Ethics Committees based in Delhi NCR.
• Protocols developed as per ICH E6 (R2), WHO TRS, and CDSCO guidelines.
Comparative Dissolution Profiling (CDP)
• Required for formulation development, generic submissions, FDC approvals, and post-approval variations.
• Conducted in pharmacopoeial (IP/USP/EP) and biorelevant media.
• f2 similarity factor for dissolution profile comparison.
• Model-independent & model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-based biowaiver justification per CDSCO, ICH Q6A, and WHO TRS.
• Level A/B/C IVIVC modeling for robust PK-predictive dissolution.
• Supports waiver of in vivo studies when applicable.
Analytical Method Development & Validation
• LC-MS/MS & HPLC-UV platforms for sensitive and robust quantification.
• Validation per ICH M10 and CDSCO method validation guidelines.
• Stability studies (accelerated & long-term) for APIs & formulations.
Pharmacokinetic (PK) & Statistical BE Analysis
• Non-compartmental PK analysis (NCA).
• BE evaluation using 90% CI acceptance intervals.
• Sample-size & power optimization for regulatory compliance.
📑 CDSCO-Ready Documentation for Delhi NCR Submissions
We prepare complete regulatory documentation for Indian and global filings:
• 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) for Form 44 regulatory submission
✨ Why Choose BioEquiGlobal for Delhi NCR?
• Proximity to CDSCO Headquarters (New Delhi): Ensures regulatory clarity and smooth communication.
• Strong CRO Presence: Direct support for Delhi NCR’s major CROs, hospitals, bioanalytical labs & research institutions.
• Regulatory Expertise: Deep understanding of NDCTR, CDSCO guidelines, and global dossier formats.
• State-of-the-Art Facilities: NABL-certified analytical labs and accredited clinical study centres integrated with QA systems.
• Global Submission Capability: ANDA/eCTD preparation for USFDA & worldwide agencies.
🗺️ BA/BE Study Workflow for Delhi NCR Pharma Sponsors
Feasibility & Regulatory Assessment
(Reference product identification, CDSCO guideline mapping, biowaiver eligibility)Protocol Design & Ethics Approval
(Submission to Delhi NCR–based IECs)Analytical Method Development & Validation
(LC-MS/MS method design per ICH M10)Clinical BA/BE Study Execution
(GCP-compliant dosing, PK sampling & safety monitoring)Bioanalysis & PK/BE Evaluation
(Validated PK modeling, QC checks & BE statistics)Submission-Ready Documentation
(CSR, CDP report, validation package & CTD modules)
Who We Support in Delhi NCR
• Formulation development & generic drug manufacturers
• CROs, hospitals, clinical trial units & academic research centres
• Bioanalytical laboratories & R&D organizations
• Export-oriented formulation companies targeting regulated markets
• Start-ups and innovators entering pharmaceutical development