A Few Tips for Pharma/Biotech/Device Professionals

When face-to-face with the FDA:

  • Get the CRITICAL discussions and questions taken care of first, in case meeting time runs out.
  • Seek agreement: “Do you agree?” (shows confidence, avoids open-ended questions)
  • Support questions with data/info: Be sure to know all of the possible answers, so there are no surprises; research first if needed.


  • In many cases, a vendor’s first personal interaction with a sponsor will be the QA Auditor. The auditor has the opportunity to set the tone for the relationship between the two companies at the outset.
  • Start compliance programs/systems early on. It’s fast/easy for things to get out of hand. It takes lots of time and $$ to go backwards and “clean up,” versus keeping things clean from the start.

Nonclinical CRO selection: 

  • Don’t hand off your study to the CRO. You, as the sponsor company are ultimately responsible for the study, so stay involved from start to finish. Don’t lose the control.

When managing a clinical trial:

  • When it comes to your protocol . . . put yourself in the shoes of the site staff AND the patient.
  • Your study is never as important to the site as it is to you . . . keep yourself front and center!

Regulatory Submissions:

  • Are you in the pre-IND phase or pre-NDA phase? No matter your answer…start using the CTD format for your product(s) as early on in the process as you can. It’s never too early to start adopting the format! Although CTD format is not required until the NDA electronic submission (e-CTD), if you start early (pre-IND phase), you will save yourself a ton of headache, time, and money when it comes time to preparing your NDA.
  • Use the CTD format for other documents in addition to clinical trial and marketing applications. If you use the same format for your investigator brochures (IB), annual reports (AR), internal nonclinical study reports etc., you will save yourselves a lot of time with organizing and typing information. This will allow the information to be much more transferrable across documents via our favorite writing tool known as, “cut and paste!”