Our Subject Matter Experts, Your Extended Team

Our team of industry veterans brings you decades of experience in the fields of Process Development, Quality Assurance, Quality Control and Regulatory Affairs.

Expediting your path to GMP manufacturing

We are dedicated to supporting our customers in their rapid transition from pre-clinical studies to clinical application and commercialization of their novel technologies.

Quality Assurance and Quality Control Support

Quality System Design & Implementation / Assay Development / Analytical Testing

Regulatory Affairs Support

Gap & Risk Analyses / CMC Strategy / Documentation

Process Development Support

Custom Supply Chain Implementation / cGMP Process Development / Scale-up and Scale-out Strategies and CoGs / Tech Transfer Plans