Providing assistance with initial packet submissions, follow-up, protocol amendments, safety reporting, responses to FDA requests for information, and annual reporting
What to Expect
Prior to and during submission to the FDA:
- Respond to general requests for information from investigators
- Meet with investigators to provide guidance and answer questions about FDA submissions
- Provide assistance with preparation of packets for submission, including a general template for submission of IND/IDE, forms (e.g.1571-1572), letters (with institutional signatures), study protocol and data, etc.
- Edit for clarity and conformance with FDA expectations (clinically and scientifically)
- Format, copy and assemble final documents, including accompanying CDs and copies and facilitate submission
- Format applications for electronic submission as applicable.
- Coordinate institutional reviews and signatures
Following Submission to FDA:
- Assist with FDA communications and questions
- Maintain records of and tracking of all submissions via electronic database and hard copy files
- Coordinate and submit annual reports
- Review, prepare and submit amendments or responses required by FDA
- Assist with safety reporting
Need a consult or have a general question?
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