Celerion’s proven expertise in BA/BE studies combines regulatory compliance with operational excellence to deliver reliable, high-quality data for your generic drug development programs.
Bioavailability & Bioequivalence (BA/BE) Studies for Generic Drug Development
Key Capabilities
PROVEN REGULATORY EXCELLENCE with positive FDA inspection history, demonstrating consistent compliance, quality standards, and inspection readiness across all study types
INVESTIGATIONAL PRODUCT RETENTION established on-site for supply chain reliability
PROTOCOL DEVELOPMENT SUPPORT with writers and scientists experienced in BA/BE study design and regulatory requirements
ROBUST PARTICIPANT RECRUITMENT supported by a large, well-maintained volunteer database
EXPERT SAMPLE HANDLING by experienced phlebotomists, ensuring sample integrity from collection through processing and shipment
ON-SITE LICENSED PHARMACISTS for investigational product packaging and preparation
BIOANALYTICAL SERVICES for validated analysis with single vendor responsibility, faster turnaround, eliminating external lab delays, and direct clinic-lab communication
ON-SITE CAP/CLIA-CERTIFIED CLINICAL LABORATORY with 24/7 coverage for rapid turnaround of laboratory values
24-HOUR MEDICAL COVERAGE with full-time investigators providing oversight and training
STANDARDIZED MEAL PREPARATION by registered dietitians in an on-site kitchen, ensuring consistency with food intake requirements
Comprehensive paperless ecosystem featuring ClinQuick™ EDC, Veeva Vault integration (eICF, eISF, eCOA, eTMF), and proprietary Celexus platform delivering 21 CFR Part 11 validated systems with real-time data visualization, automated quality checks, and seamless sponsor portal access for immediate study oversight
AAHRPP-accredited facilities meet the highest standards for human research protection