Regulatory Affairs

VCTRS supports the University’s research mission through providing services to UVA Faculty and Project teams pursuing advancement of research projects and ideas to clinical testing.

The Center also works with the broader academic medicine and biotechnology communities to generally support the regulatory advancement of novel technologies and innovative ideas.

VCTRS provides the following services in Regulatory Affairs:

(1)    General consulting on regulatory needs, approaches and strategy

(2)    FDA communications

(3)    Planning for and support of FDA meetings including Pre-IND and Pre-IDE meetings

(4)    Support for regulatory filings including INDs and IDEs (Advise content and organization, review submissions)

(5)    Preclinical & Clinical program development (strategy, project coordination)

(6)    Project management and coordination to ensure timely progression of project goals

(7)   Pre-Award clinical, regulatory and translational (commercialization) section authoring and review

 

Request a consultation for your project by contacting the center.  Please refer to the Public Health Sciences Department’s Consulting and Collaboration Support webpage for more information on our Consulting policies.  We currently offer 4 hours of consulting time free of charge.