Bioavailability & Bioequivalence (BABE) Services
Genelife Clinical Research provides comprehensive Regulatory, Project Management, Site Management, and Monitoring services for BA/BE studies. We help clients choose the best CRO partners as per their regulatory needs, with close associations with leading BA/BE CROs across India, Singapore, and the Middle East — making us a complete CRO in India for BABE studies.
Site Selection Services
- Expertise Assessment: Evaluating potential BA/BE sites based on expertise, track record, infrastructure, and staff qualifications
- Regulatory Compliance: Ensuring selected sites adhere to GCP standards, ethical considerations, and local regulatory requirements (CDSCO, FDA, EMEA)
- Logistics & Resources: Evaluating availability of facilities, equipment, and resources for sample collection, bioanalysis, and data management
- CRO Network: Access to leading BA/BE facilities in India (Hyderabad, Ahmedabad, Bangalore, Mumbai), Singapore, and Middle East countries
Site Management Services
- Quality Assurance: Robust QA/QC systems to monitor site performance, data accuracy, and protocol compliance throughout the study
- Training & Certification: Comprehensive training for site personnel on standardized procedures, protocol requirements, and GCP obligations
- In-Process Monitoring: Regular monitoring of study-related activities, sample collection procedures, and protocol adherence at all sites
- Regulatory Submissions: Preparation and submission of all regulatory documentation for BA/BE study approval from CDSCO and other agencies
India BA/BE Sites
Strong partnerships with accredited BA/BE facilities in Hyderabad, Ahmedabad, Bangalore, and Mumbai — covering both fasted and fed study requirements with qualified bioanalytical support.
International Partners
Close working relationships with leading European CROs and established partnerships with BA/BE facilities in Singapore and the Middle East for international generic drug submissions.
One-Stop BA/BE Support: From study design and regulatory strategy to site selection, monitoring, and final submission — Genelife provides comprehensive BABE services as a trusted CRO in India for generic pharmaceutical companies worldwide.