Device CRO - Contract Research Organization

Clinical Studies

Your CRO for cost-effective
medical device, in vitro diagnostic
device, drug or combination product US and European clinical studies for worldwide acceptance.

[ enter ]

Medical Devices

A trusted resource for US and EU medical device regulatory and quality system requirements also providing EU Authorized Representative and US Agent services.

[ enter ]

In Vitro Diagnostics

IVDs have distinct requirements in both the US and Europe. We have the IVD regulatory, quality system and clinical study expertise needed for US and European market entry.

[ enter ]

Pharmaceuticals

Helping meet European drug regulatory requirements, including development of drug dossiers for Class III devices with ancillary medicinal substances.

[ enter ]

For over 20 years, we have helped life science companies
enter the European and US markets, meet post-market requirements,
and maintain compliance pragmatically and effectively.