🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Noida
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 pharmaceutical, biotech, CRO, and analytical organizations across Noida & Greater Noida, one of India’s most advanced industrial and research hubs.
All services fully comply 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 submissions to CDSCO/DCGI, as well as global regulatory agencies including USFDA, EMA, MHRA, TGA, Health Canada, SAHPRA, and others.
💊 Core BA/BE Services for Noida’s Pharma, CRO & Biotech Sector
Clinical BA/BE Studies (Human)
• Single-dose & multiple-dose BE studies (crossover & parallel designs).
• Healthy volunteer & patient-specific studies depending on therapeutic class.
• IEC approval through CDSCO-registered Ethics Committees within Noida/Delhi NCR.
• BE protocols developed as per ICH E6 (R2), WHO TRS, and CDSCO guidance.
Comparative Dissolution Profiling (CDP)
• Required for generic drug filings, FDC approvals, and formulation optimization.
• Pharmacopoeial (IP/USP/EP) and biorelevant dissolution media.
• f2 similarity factor calculation to compare dissolution profiles.
• Model-independent & model-dependent dissolution analysis.
IVIVC & Biowaiver Support
• BCS-based biowaivers prepared in accordance with CDSCO, WHO TRS, and ICH Q6A.
• Level A/B/C IVIVC modeling for predictive in vitro–in vivo correlation.
• Supports waiver of in vivo BE studies where applicable.
Analytical Method Development & Validation
• LC-MS/MS and HPLC-UV bioanalytical platforms.
• Validation per ICH M10 & CDSCO bioanalytical method validation requirements.
• Stability-indicating methods for APIs and finished formulations.
Pharmacokinetic (PK) & BE Statistical Evaluation
• Non-compartmental PK analysis (NCA).
• BE assessment complying with standard 90% CI acceptance criteria.
• Power analysis and sample-size determination for regulatory compliance.
📑 CDSCO-Ready Documentation for Noida Sponsors
We prepare full regulatory documentation packages including:
• Clinical Study Protocol
• Informed Consent Form (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 or international submissions
✨ Why Choose BioEquiGlobal for Noida?
• Strategic NCR Location: Noida’s proximity to Delhi & CDSCO HQ facilitates smoother coordination and faster regulatory processes.
• Growing CRO & R&D Hub: Noida and Greater Noida host major CROs, analytical labs, medical institutions, and biotech clusters.
• Advanced Infrastructure: Access to NABL-accredited labs and GCP-compliant clinical trial facilities.
• Global Submission Capability: Expertise in ANDA, CTD, eCTD dossiers for regulated and semi-regulated markets.
• Customizable BE Solutions: Ideal for start-ups, SMEs, and large pharma manufacturers.
🗺️ BA/BE Study Workflow for Noida-Based Sponsors
Feasibility & Regulatory Assessment
(Reference product evaluation, CDSCO gap analysis, biowaiver feasibility)Protocol Development & IEC Approval
(Ethics submission to NCR-based IECs)Analytical Method Development & Validation
(LC-MS/MS validation as per ICH M10)Clinical BA/BE Study Execution
(Volunteer recruitment, dosing, PK sampling, safety monitoring)Bioanalysis & PK/BE Evaluation
(PK modeling, QC checks, BE statistical calculations)Documentation & Submission
(CSR, CDP report, analytical validation & CTD modules)
Who We Support in Noida
• Pharmaceutical & generic drug manufacturers
• CROs and clinical research units
• Bioanalytical laboratories
• Biotech and formulation R&D companies
• Export-oriented pharmaceutical businesses
• Start-ups entering regulated markets