:

🇮🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services – Baddi, Himachal Pradesh

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 Baddi, India’s largest formulation manufacturing and contract manufacturing hub. We support generic, specialty, and export-oriented pharmaceutical companies with fully CDSCO, DCGI, ICH-GCP, and OECD-GLP compliant clinical research solutions.

With Baddi being a powerhouse for tablet, capsule, injectable, and syrup manufacturing, our BA/BE services are strategically designed to support India, US, Europe, Canada, GCC, and global regulatory submissions.

✅ Our Core BA/BE Study Services – Baddi

🧪 Bioequivalence (BE) Studies
• Fasted & fed studies
• Immediate-release (IR) & modified-release (ER/DR/MR) products
• 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 – Baddi Support

• Phase I clinical trials (partner clinical units)
• BE protocol development & 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 Baddi-based pharmaceutical manufacturers for:

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

Deliverables include:
• 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 Baddi?

✅ Specialized support for formulation & CMO-driven companies
✅ CDSCO & ICH-GCP compliant operations
✅ US FDA & EMA-aligned study designs
✅ Advanced LC-MS/MS bioanalytical capabilities
✅ Short turnaround timelines
✅ Cost-effective BE study execution
✅ Strong global regulatory submission expertise
✅ Backed by Zoesoe Exports Pvt Ltd’s regulatory strength

🏭 Industries We Support in Baddi

• Finished formulation manufacturers (FDF)
• Contract manufacturing organizations (CMOs)
• Export-oriented pharma companies
• Specialty & nutraceutical manufacturers
• 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 Baddi

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

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