BioAgile Therapeutics

Overview

BioAgile Therapeutics is a privately-owned, full-service Clinical Research Organization (CRO) headquartered in Bangalore, India, with 15+ years of experience delivering clinical research solutions to Indian and global sponsors.

Regulatory & Quality

• CDSCO Approved CRO (Registration No. CRO/KA/2026/000173) under the Central Drugs Standard Control Organization, Government of India
• ISO 9001:2015 Certified Quality Management System
• ICH-GCP Aligned operations
• 21 CFR Part 11 Compliant electronic records management

Core Services

• Clinical Trials: Phase I to Phase IV, post-marketing surveillance (PMS)
• Regulatory & Compliance: Regulatory submissions, ICH-GCP guidance, submission-ready documentation
• Data & Analytics: Clinical data management, biostatistics, clinical quality assurance
• Medical & Scientific: Medical writing, safety assessment, efficacy evaluation, label claims substantiation
• Specialized Studies: BA/BE studies, preclinical services, biotech support (biosimilar development, cell line studies)

Industry Expertise

Serves pharmaceuticals, nutraceuticals, cosmeceuticals, medical devices, software as a medical device (SaMD), biotechnology, Ayurvedic & herbal products, and veterinary sectors.

Engagement Model

Offers flexible resource models (onsite, offshore, hybrid) with dedicated project managers, direct team access, and integrated collaboration with central labs, regulatory affairs, and supply partners. Trusted by 100+ clients, supported by 10,000+ volunteers and 30+ scientific publications.