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

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

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling designed to support pharmaceutical, biotech, CROs, and R&D companies across Hyderabad, India’s premier life sciences and clinical research capital.

All studies comply with:

• CDSCO (Central Drugs Standard Control Organization)

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

• ICH GCP & GLP

• WHO Technical Report Series (TRS)

• ICMR Ethical Guidelines

We support regulatory submissions for CDSCO/DCGI, as well as global agencies including USFDA, EMA, MHRA, TGA, Health Canada, SAHPRA, GCC, and more.

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

Clinical BA/BE Studies (Human)

• Single-dose & multiple-dose BE studies (crossover & parallel).
• Healthy volunteer studies and special population/patient studies when required.
• IEC approval through CDSCO-registered Ethics Committees across Hyderabad.
• Protocol development aligned with ICH E6 (R2), WHO TRS, and CDSCO requirements.

Comparative Dissolution Profiling (CDP)

• Mandatory for generic filings, FDC approvals, and formulation optimization.
• Conducted in pharmacopoeial (IP/USP/EP) & biorelevant media (FaSSIF, FeSSIF).
• f2 similarity factor for evaluating dissolution equivalence.
• Model-dependent and model-independent CDP evaluations.

IVIVC & Biowaiver Support

• BCS-based biowaivers prepared per CDSCO, ICH Q6A, and WHO TRS.
• Level A/B/C IVIVC modeling for predictive in vitro–in vivo correlation.
• PK modeling to support in vivo BE waiver justification.

Analytical Method Development & Validation

• Advanced LC-MS/MS, HPLC-UV, and stability-indicating analytical methods.
• Analytical validation per ICH M10 and CDSCO bioanalytical standards.
• Stability studies (accelerated & long-term) for APIs and finished dosage forms.

Pharmacokinetic (PK) & Statistical BE Analysis

• Non-compartmental PK analysis (NCA).
• BE assessment using 90% CI statistical acceptance criteria.
• Sample-size & power calculations for optimal study design.

📑 CDSCO-Ready Documentation for Hyderabad Submissions

We prepare complete documentation for both domestic and international regulatory submissions:

• 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 and global filings

✨ Why Choose BioEquiGlobal for Hyderabad?

• India’s #1 Pharma Manufacturing & R&D Hub: Hyderabad hosts pharma giants, biosimilar developers, CROs, and analytical labs.
• Strong Regulatory Advantage: Deep experience working with CDSCO, NDCTR rules, and international regulatory gateways.
• Cutting-Edge Infrastructure: Access to leading BA/BE clinical centers, NABL-certified analytical labs, and advanced LC-MS/MS platforms.
• Export-Focused Expertise: Dossier development for ANDA, MAAs, CTDs, and global regulatory submissions.
• End-to-End Partner: Perfect for formulation development, BE studies, analytical validation, and regulatory documentation.

🗺️ BA/BE Study Workflow for Hyderabad Sponsors

1. Feasibility & Regulatory Gap Assessment
   (Reference product availability, CDSCO mapping, biowaiver eligibility)

2. Protocol Development & IEC Approval
   (Ethics submission to Hyderabad-based committees)

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

4. Clinical BA/BE Study Execution
   (GCP-compliant recruitment, dosing, PK sampling, safety monitoring)

5. Bioanalysis & PK/BE Evaluation
   (PK modeling, QC checks & statistical BE analysis)

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

Who We Support in Hyderabad

• Formulation development companies
• Biotech & biosimilar developers
• Pharmaceutical manufacturers (domestic & export-driven)
• CROs & clinical trial units
• Bioanalytical laboratories
• Start-ups in drug development & innovation