🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Gurgaon

CDSCO-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides end-to-end Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for pharmaceutical manufacturers, CROs, hospitals, biotech companies, and R&D units operating in Gurgaon (Gurugram) — one of India’s most advanced life-sciences and corporate hubs.

All studies 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 regulatory submissions for CDSCO/DCGI, as well as global agencies including USFDA, EMA, MHRA, TGA, Health Canada, and others.

💊 Core BA/BE Services for Gurgaon-Based Pharmaceutical & CRO Ecosystem

Clinical BA/BE Studies (Human)

• Single-dose and multiple-dose BE study designs (crossover/parallel).
• Healthy volunteer & patient-focused studies as per therapeutic need.
• IEC approval through CDSCO-registered ethics committees across Gurgaon/Delhi NCR.
• Protocol development aligned with ICH E6 (R2), WHO TRS & CDSCO guidance.

Comparative Dissolution Profiling (CDP)

• Required for generic drug submissions, FDC approvals, and formulation modifications.
• Dissolution testing in pharmacopoeial (IP/USP/EP) and biorelevant media (FaSSIF/FeSSIF).
• f2 similarity factor for dissolution profile comparison.
• Comprehensive model-independent and model-dependent dissolution analysis.

IVIVC & Biowaiver Support

• Preparation of BCS-based biowaivers per CDSCO, WHO TRS, and ICH Q6A.
• Level A/B/C IVIVC models to support in vivo BE waiver strategies.
• PK-predictive modeling for regulatory justification.

Analytical Method Development & Validation

• Advanced LC-MS/MS, HPLC-UV, and stability-indicating analytical methods.
• Bioanalytical validation following ICH M10 and CDSCO norms.
• Stability studies for drug substances and finished pharmaceutical products.

Pharmacokinetic (PK) & BE Statistical Analysis

• Non-compartmental PK analysis (NCA).
• BE evaluation using standard 90% CI acceptance criteria.
• Power & sample-size calculation based on PK variability.

📑 CDSCO-Compliant Documentation for Gurgaon-Based Sponsors

We prepare full regulatory documentation packages, including:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per CDSCO & ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) for CDSCO (Form 44) or export submissions

✨ Why Choose BioEquiGlobal for Gurgaon?

• Corporate & R&D Hub: Gurgaon hosts top pharma/biotech offices, CRO headquarters, and innovation labs — ideal for centralized BE coordination.
• Regulatory Advantage: Proximity to CDSCO HQ & NCR clinical sites speeds up approvals and study execution.
• Premium Infrastructure: NABL-certified analytical labs, state-of-the-art LC-MS/MS systems, and accredited clinical research units nearby.
• End-to-End Global Dossier Support: ANDA, CTD, eCTD submissions for all regulated markets.
• Flexible Engagement: Ideal for both established pharma majors and fast-growing start-ups in Gurgaon.

🗺️ BA/BE Study Workflow for Gurgaon Sponsors

1. Feasibility Assessment & CDSCO Gap Review
   (Reference product selection, biowaiver evaluation, regulatory mapping)

2. Protocol Development & IEC Approval
   (Ethical submissions across Gurgaon/Delhi NCR institutions)

3. Analytical Method Development & Validation
   (LC-MS/MS validation per ICH M10)

4. Clinical Study Execution
   (GCP-compliant volunteer recruitment, dosing, sampling, safety monitoring)

5. Bioanalysis & PK/BE Assessment
   (PK modeling, QC verification, statistical BE calculations)

6. Final Documentation & Submission
   (CSR, CDP report, validation package & CTD-ready modules)

Who We Support in Gurgaon

• Pharmaceutical & formulation development companies
• CROs, hospitals & clinical research facilities
• Biotech and biosimilar developers
• Bioanalytical laboratories
• Export-oriented pharma units targeting global regulated markets