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, investigator brochures, 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
  • 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? 
Contact Dunia Ritchey at This email address is being protected from spambots. You need JavaScript enabled to view it. or 205-492-5703