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

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 pharmaceutical companies, CROs, formulation R&D teams, biotech organizations, and analytical units across Pune, a major innovation and industrial centre in Maharashtra.

All studies strictly follow:

• CDSCO (Central Drugs Standard Control Organization)

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

• ICH GCP & WHO TRS

• GLP guidelines

• ICMR Ethical Standards

We support CDSCO/DCGI submissions, as well as regulatory filings to USFDA, EMA, MHRA, TGA, Health Canada, and other global agencies.

💊 Core BA/BE Services for Pune’s Pharma, Biotech & CRO Ecosystem

Clinical BA/BE Studies (Human)

• Single-dose & multiple-dose BE studies (crossover & parallel).
• Healthy volunteer and patient-based studies as applicable.
• IEC approval through CDSCO-registered Ethics Committees in Pune.
• Protocols developed following ICH E6 (R2), WHO TRS & CDSCO guidelines.

Comparative Dissolution Profiling (CDP)

• Required for Form 44 submissions, generic approvals, post-approval variations, and formulation optimization.
• Dissolution studies conducted in IP/USP/EP & biorelevant media (FaSSIF/FeSSIF).
• f2 similarity factor–based profile comparison.
• Model-independent & model-dependent dissolution evaluations.

IVIVC & Biowaiver Support

• BCS-based biowaiver development as per CDSCO, ICH Q6A, and WHO TRS frameworks.
• Level A/B/C IVIVC models for in vitro–in vivo predictivity.
• Dissolution–PK modeling to support in vivo waiver justification.

Analytical Method Development & Validation

• LC-MS/MS, HPLC-UV, and stability-indicating methods.
• Method validation per ICH M10 & CDSCO bioanalytical standards.
• Stability studies for API & final dosage forms.

Pharmacokinetic (PK) & BE Statistical Analysis

• Non-compartmental PK analysis (NCA).
• BE evaluation via 90% confidence interval BE acceptance range.
• Sample-size & power calculations for robust study designs.

📑 CDSCO-Compliant Documentation for Pune Submissions

We prepare complete regulatory documentation packages, including:

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

✨ Why Choose BioEquiGlobal for Pune?

• Pharmaceutical & Biotech Innovation Hub: Pune has a large ecosystem of formulation developers, biotech start-ups, and CROs — ideal for BE coordination.
• Skilled R&D Workforce: Strong academic & industrial presence (NCL, IISER, biotech parks).
• Modern Infrastructure: Access to NABL-certified analytical labs and GCP-compliant clinical research units.
• Global Regulatory Expertise: CTD/eCTD dossier preparation for regulated markets.
• End-to-End Development Partner: From method development to BE studies and final submission.