Quality assurance support for medical devices, drugs, biologics, diagnostics, and tissue products.

Chemistry Manufacturing and Control

Pharmaceutical and Biologics specific manufacturing processes, product characterization and testing.


Biomedical products regulatory support to ensure compliance with laws and regulations.

Global Coverage

Consulting support for Global regions and countries including: United States, Europe, Australia, South America, Canada, China, and Japan.


Current good manufacturing practices for: Medical Devices, Pharmaceuticals, In Vitro diagnostics, Biologics, and HCT/P.

Regulatory Documentation and Submissions

FDA submission documents including; 510k, IND (Investigational New Drug) , TMF (Trial Master File),
European Union Technical Documentation / Clinical Evaluation Report (CER)

Peter Knauer
Moj Eram, PhD