Assay Development & Validation

Our Analytical Team has decades of experience in assay development and full validation of test methods and processes. We specialize in working with small organizations and start-ups, getting their groundbreaking ideas and technologies to commercialization, offering more attention and detail to a project than the large contract manufacturers are able to provide.

Below, you'll find a brief listing of services offered.

AnalyticalMethod Setup
Method Validation
Batch QC
Product Characterization
ProcessMethod Development
Process Setup
GLP/Engineering Batch Production
cGMP Production
Viral ClearanceCRO Studies
• Full Project Support and Management                
Stability StudiesCRO Studies
• Full Project Support and Management
• Real-Time, Accelerated and Stress-Testing             
Regulatory DocumentationCMC Documentation