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

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

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for the rapidly growing pharmaceutical, biotech, and clinical research ecosystem in Bangalore, Karnataka.

All services adhere to:

• CDSCO (Central Drugs Standard Control Organization)

• New Drugs & Clinical Trials Rules (NDCTR), 2019

• ICH GCP & GLP

• WHO TRS

• ICMR Ethical Guidelines

We support regulatory submissions for CDSCO/DCGI, USFDA, EMA, MHRA, TGA, Health Canada, and other international authorities.

💊 Core BA/BE Services for Bangalore’s Pharma, Biotech & CRO Sector

Clinical BA/BE Studies (Human)

• Study designs: Single-dose & multiple-dose, crossover & parallel studies.
• Volunteer recruitment: Healthy individuals and patient-specific studies.
• Ethics compliance: IEC approval through CDSCO-registered Ethics Committees in Bangalore.
• Protocol development aligned with ICH E6 (R2), WHO TRS, and CDSCO guidelines.

Comparative Dissolution Profiling (CDP)

• Mandatory for NDA/ANDA-equivalent submissions, FDC approvals, and formulation changes.
• Dissolution Media: Biorelevant (FaSSIF/FeSSIF) & pharmacopoeial (IP/USP) media.
• f2 similarity factor for dissolution curve comparison.
• Model-independent and model-dependent dissolution assessment.

IVIVC & Biowaiver Support

• BCS-based biowaiver development per CDSCO, ICH Q6A, and WHO TRS.
• Level A/B/C IVIVC models for dissolution–PK correlation.
• Predictive PK modeling to support regulatory justification.

Analytical Method Development & Validation

• Techniques: LC-MS/MS, HPLC-UV, and stability-indicating analytical methods.
• Validation per ICH M10 & CDSCO bioanalytical guidelines.
• Complete stability studies for APIs & finished pharmaceutical products.

Pharmacokinetic (PK) & Statistical BE Analysis

• Non-compartmental PK analysis (NCA).
• Standard 90% CI–based BE assessment.
• Sample size & power calculation based on variability and CDSCO expectations.

📑 CDSCO-Ready Documentation for Bangalore-Based Sponsors

We prepare complete regulatory documentation for DCGI submissions:

• Clinical Study Protocol
• Informed Consent Forms (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per CDSCO structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) for Form 44 filings

✨ Why Choose BioEquiGlobal for Bangalore?

• Hub of Innovation: Bangalore is India’s leading biotech & pharma R&D centre — we support its advanced development needs.
• Strong Regulatory Understanding: Expertise in NDCTR, CDSCO expectations, and IEC-driven compliance.
• Robust Infrastructure: Access to NABL-certified analytical labs, high-end LC-MS/MS platforms, and accredited clinical units.
• Global Market Support: Dossier preparation for USFDA, EMA, MHRA, TGA, Health Canada, WHO PQ, and GCC regulators.
• Ideal for End-to-End Development: From dissolution and BE study design to complete regulatory dossier submission.

🗺️ BA/BE Study Workflow for Bangalore Sponsors

1. Feasibility & Regulatory Strategy
   (Biowaiver eligibility, reference product assessment, CDSCO gap analysis)

2. Protocol Development & IEC Approval
   (Bangalore-based IEC submissions)

3. Analytical Method Development
   (LC-MS/MS method design and validation per ICH M10)

4. Clinical Study Execution
   (Volunteer recruitment, GCP-compliant dosing, sampling, and monitoring)

5. Bioanalysis & PK Evaluation
   (PK modeling, QC verification, and BE statistics)

6. Submission Package Preparation
   (CSR, CDP report, validation documents & CTD modules)

Who We Support in Bangalore

• Pharmaceutical formulation manufacturers
• Biotech companies developing novel & biosimilar products
• CROs & bioanalytical labs
• R&D centres and start-ups
• Export-focused pharmaceutical units targeting regulated markets