Regulatory assistance is available to help researchers understand and meet the many regulatory and compliance requirements. Assistance is available for:
- Determination of product classification (i.e., drug, device, combination product, biologic).
- Applicability of an IND or IDE.
- Assistance with submission of an IND or IDE application.
- Preparation, coordination, facilitation, and attendance at FDA meetings.
- Preparation for regulatory support during FDA inspections of investigator sponsored clinical trials.
- Provide information about new guidance documents, inspection trends, inspection actions and new regulatory actions taken by FDA relating to clinical trials.
We work closely with the Research Project Navigators to identify projects that may need IND or IDE assistance; to clarify and provide support the FDA mandated obligations of sponsor/investigators.
We also work with with sponsor/investigators to facilitate pre-IND, IND or IDE meetings with the FDA. RAP provides guidance to the investigator during the preparation process (slides and document preparation, proper inquiry format and process, subject matter preparation and communication) and will attend FDA meetings as facilitator, when requested.
Wajeeh Bajwa (firstname.lastname@example.org) – (352) 273-8702