ÄStrategic Planning

We collaborate with researchers and other members of the product team to design an integrated development plan based on the science underlying the investigational product.

ÄGuidance in Clinical and Regulatory Affairs

We advise on regulatory strategy and implementation of regulations and policies for conducting clinical trials. We also advise on Class I exempt medical devices and 510(k) submissions

ÄProject Management

We provide oversight for overall program projects and activities, including adherence to timelines and budgets.

ÄDocument and Communications Support

We prepare corporate presentations, regulatory submissions, clinical documents and training programs.

ÄPolicy Development

We develop policies that are compliant with Good Clinical Practices and other regulatory standards for conducting human research.