Project: Regulatory Affairs Consultant Services for NINDS Biotechnology Products and Biologics

Sponsor: NIH/National Institute of Neurological Disorders and Stroke (NINDS)

Prime: Rho

Project Status: Active

Start Date: September 2016

Diseases: NINDS conducts research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.

Project Information: Rho serves as the Regulatory Affairs Consultant Services contractor for the NINDS Cooperative Research to Enable and Advance Translational Enterprises for Biotechnology Products and Biologics (CREATE Bio) program. In this capacity, Rho provides senior-level, industry-experienced discovery and development biologics regulatory affairs consultants with expertise in biotechnology products and biologics. Rho’s team of 6 consultants provides the following services to NINDS:

• Advises NINDS staff on FDA regulatory guidelines, regulations, and requirements
• Advises on and reviews IND packages
• Integrates regulatory guidance with research plans
• Provides preparation guidance for pre-IND and IND meetings
• Reviews FDA responses to recommend new courses of action
• Reviews, identifies, and assesses regulatory risks and gaps to IND-enabling research study plans and recommends solutions
• Provides oral presentations and trainings to NINDS staff and NINDS-funded investigators in areas of expertise

Phase(s): Early discovery stage through early-phase clinical trials