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

CDSCO-Compliant BA/BE & Clinical Research Solutions

By BioEquiGlobal – A Scientific Arm of Zoesoe Exports Pvt Ltd

BioEquiGlobal provides end-to-end Bioavailability (BA) and Bioequivalence (BE) study services for pharmaceutical companies in Ankleshwar, one of India’s largest API and formulation manufacturing hubs. We support generic, specialty, and export-oriented pharma companies with fully CDSCO, DCGI, ICH-GCP, and OECD-GLP compliant clinical research solutions.

With Ankleshwar being a backbone of India’s bulk drug and formulation industry, our BA/BE services are strategically designed to support India, US, Europe, Canada, GCC, and global regulatory submissions.

✅ Our Core BA/BE Study Services – Ankleshwar

🧪 Bioequivalence (BE) Studies
• Fasted & fed studies
• Immediate-release (IR) & modified-release (ER/DR/MR)
• Fixed-dose combinations (FDCs)
• Complex generics
• Oral solids, liquids, 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 – Ankleshwar Support

• Phase I clinical trials (partner clinical sites)
• BE protocol design & scientific justification
• Ethics Committee (EC) approvals
• DCGI / CDSCO clinical trial permissions
• Clinical site coordination
• Subject recruitment & screening
• Clinical monitoring & quality assurance
• 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 for Ankleshwar-based pharmaceutical companies for:

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

Key deliverables include:
• Study protocols, ICFs & CRFs
• Integrated Clinical, PK & Statistical Reports
• CTD Module 5 preparation
• Scientific justifications & deficiency response support

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

✅ Strong experience with API & formulation manufacturers
✅ CDSCO & ICH-GCP compliant operations
✅ US FDA & EMA-aligned study designs
✅ Advanced LC-MS/MS bioanalytical capabilities
✅ Rapid study initiation & execution
✅ Cost-effective BE study solutions
✅ Strong global regulatory submission support
✅ Backed by Zoesoe Exports Pvt Ltd’s regulatory expertise

🏭 Industries We Support in Ankleshwar

• API manufacturers
• Finished formulation (FDF) manufacturers
• Export-oriented pharma companies
• Contract development & manufacturing organizations (CDMOs)
• Specialty chemicals & life science 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 Ankleshwar

Whether you are planning a generic BE study, executing a biowaiver strategy, or preparing for US FDA, EMA, or DCGI approval, BioEquiGlobal delivers regulator-ready, scientifically robust, and globally accepted BA/BE study solutions for Ankleshwar-based pharmaceutical companies.

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