🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services – Ahmedabad, Gujarat

CDSCO-Compliant BA/BE & Clinical Research Solutions

By BioEquiGlobal – A Scientific Arm of Zoesoe Exports Pvt Ltd

BioEquiGlobal offers end-to-end Bioavailability (BA) and Bioequivalence (BE) study services in Ahmedabad, supporting generic, specialty, and export-oriented pharmaceutical companies with fully CDSCO, DCGI, ICH-GCP, and OECD-GLP compliant clinical research solutions.

Ahmedabad is one of India’s fastest-growing pharmaceutical and CRO hubs, making it an ideal location for high-quality, cost-effective BA/BE studies for India, US, Europe, Canada, and global markets.

✅ Our Core BA/BE Study Services – Ahmedabad

🧪 Bioequivalence (BE) Studies
• Fasted & fed studies
• Immediate-release (IR) & modified-release (ER/DR/MR)
• Fixed-dose combinations (FDCs)
• Complex generics
• Oral solid, liquid, and special dosage forms

🧪 Bioavailability (BA) Studies
• First-in-human BA studies
• Absolute & relative BA studies
• Pilot & exploratory PK studies

🧪 Comparative Dissolution & Biowaiver Support
• Multimedia dissolution profiling
• BCS Class I & III biowaiver strategy
• IVIVC & formulation optimization

🧪 Clinical Phase & Operational Services – Ahmedabad

• Phase I clinical trials
• BE protocol design & scientific justification
• Ethics Committee (EC) approvals
• DCGI / CDSCO clinical trial permissions
• Clinical site coordination
• Subject recruitment & screening
• Clinical monitoring & QA audits
• PK sample collection

🧪 GLP-Compliant Bioanalytical Services

• LC-MS/MS method development & validation
• Plasma/serum drug quantification
• Incurred Sample Reanalysis (ISR)
• Stability testing of analytes
• High-throughput PK sample analysis

🧪 Pharmacokinetic (PK) & Statistical Analysis

• Non-compartmental PK analysis
• BE statistical evaluation (ANOVA, 90% CI)
• WinNonlin & SAS datasets
• Final PK & statistical reports (India, US, EU formats)

🧪 Regulatory & Global Submission Support

We provide complete BA/BE regulatory documentation from Ahmedabad for:

• DCGI / CDSCO submissions
• US FDA ANDA filings
• EMA (Europe) submissions
• Health Canada
• GCC, LATAM & ASEAN markets

Documents include:
• Protocols, ICFs & CRFs
• Integrated Clinical, PK & Statistical Reports
• CTD Module 5 preparation
• Scientific justifications & deficiency responses

✅ Why Choose BioEquiGlobal for BA/BE Studies in Ahmedabad?

✅ CDSCO & ICH-GCP compliant operations
✅ US FDA & EMA-aligned study design
✅ Experienced Phase I units & investigators
✅ Advanced LC-MS/MS bioanalytical labs
✅ Fast subject recruitment in Western India
✅ Short timelines & cost-efficient execution
✅ Strong global regulatory approval experience
✅ Backed by Zoesoe Exports Pvt Ltd’s regulatory strength

🏭 Industries We Support in Ahmedabad

• Generic pharmaceutical companies
• Export-oriented formulation manufacturers
• API & FDF developers
• Contract manufacturing organizations (CMOs)
• Biotech & specialty pharma companies
• ANDA / CTD filing companies

📑 Regulatory Standards Followed

• Drugs & Cosmetics Act & Rules, India
• New Drugs & Clinical Trials Rules (NDCTR), 2019
• CDSCO & DCGI Guidelines
• ICH-GCP E6 (R2)
• OECD-GLP
• US FDA BA/BE Guidance
• EMA Bioequivalence Guidelines

🎯 Your Trusted BA/BE Partner in Ahmedabad

Whether you are conducting a generic BE study, planning a biowaiver, or preparing for US FDA, EMA, or DCGI submission, BioEquiGlobal delivers scientifically sound, regulator-ready, and globally accepted BA/BE study solutions from Ahmedabad.

✅ Regulatory-aligned
✅ Scientifically robust
✅ Time-efficient
✅ Globally accepted