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)
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