- Regulatory Affairs Support for “Commercial” Activities –Effort to support an investigational application where the product under investigation is intended to be commercialized at a later date, an FDA marketing application, or modification of an FDA-cleared/approved product.
- Regulatory Affairs Support for Coordinating Center Role—Effort to support large, multi-center studies or projects that require use of a coordinating center.
- Regulatory Affairs Support for Multi-Project Programs—Effort to support large, multi-project research activities, such as Program Project/Center Grants (P series), Cooperative Agreements (U01), or projects of similar magnitude.
If the needed regulatory work meets one of the criteria above, we can work with you to develop a budget of estimated costs that can be included in a grant or contract negation. To request a cost estimate for regulatory affairs support, please email ORAQ@duke.edu.
Letter of Support
In addition to providing cost estimates, ORAQ can provide a letter of support demonstrating our commitment to support your research project. To aid in the development of this letter, ORAQ has developed a template that can be downloaded and modified to describe your research proposal. Please draft the letter and email a Word version to ORAQ@duke.edu with "Request for Letter of Support" in the subject line. Be sure to include in the body of the email:
- The investigator name and department
- The relevant sponsor/program
- The deadline to the sponsor/your send date
- The name and email address of the person(s) to contact when the letter is executed
- Special formatting requirements (e.g., length, font size)
ORAQ will review the draft letter and make any edits before printing on letterhead and returning a signed copy. While execution of the letter will be completed as quickly as possible, please expect that it may take up to 2-4 business days.