RE: Solicitation Number: NIAID-SS19-1975722
The scope of this requirement is to provide regulatory operations support services for Investigational New Drug (IND) Applications sponsored by the Vaccine Research Center. Regulatory activities will ensure IND Sponsor compliance with applicable federal regulations and guidelines, ensure research is conducted ethically, human subjects are protected and data integrity is preserved.
As the IND sponsor for these products, many of which share platform technology, VRC requires integrated regulatory support across the different projects. This requires that the communications and submissions to the FDA and other regulatory agencies be carefully coordinated, consistent, and prioritized correctly. The submissions must be compliant with current FDA regulations and guidelines.
Contractor shall be experienced with FDA regulatory submissions of similar investigational products and clinical trials. VRC Office of Regulatory Science (ORS) has identified the following task areas as critical to this initiative:
- Task 1: Provide expert regulatory operations support in the preparation, compilation, publishing and filing of Investigational New Drug Application (IND) submissions in compliance with all applicable regulations and guidelines.
- Task 2: Technical writing, review, and high-level quality control.
- Task 3: Regulatory Intelligence support.
- Task 4: Document control.