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.


Method Setup

Method Validation

Batch QC

Product Characterization


Method Development

Process Setup

GLP/Engineering Batch Production

GMP Production

Viral Clearance:

CRO Studies

- Full Project Support and Management

Stability Studies:

CRO Studies 

- Full Project Support and Management

- Real-time, Accelerated and Stress Testing

Regulatory Documentation:

CMC Documentation