Consultation Request for Regulatory Services | Duke University School of Medicine

First Name

Last Name

Organization Name:

Email Address

Phone Number

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Is there any Duke connection to your company/program

Yes

Product Type

Stage of Development:

Type of Support Required. Select all that apply.

Regulatory Strategy Development

CMC Regulatory Guidance

Clinical Protocol Review

Submission Preparation & Management

Orphan Drug, Fast Track & Breakthrough Designation Application

Regulatory Publishing

FDA Meeting Support

Other type of support

Project Timeline

Project Details/Description

Do you have previous experience working with regulatory affairs services?

Please briefly describe your prior experience or previous projects.

Please describe any key regulatory requirements and/or challenges for your product development program

Any additional information or specific requests?

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