Concerned about your NDA submission?

Let the professionals at Prosoft help by reviewing your NDA from a regulatory perspective. We will prepare you for the intense scrutiny of your submission by the FDA or other regulatory agencies.

Prosoft will serve as an independent review consultant for specific portions or the entire NDA. Our review has the potential to uncover critical aspects of your submission that may be vulnerable to a regulatory review process.

Here is what we can do:

  • Inspect your NDA for completeness
  • Review all pre-clinical and clinical data
  • Review your label, pharmacokinetics, and chemistry
  • Audit databases, vendors, clinical sites, and manufacturing
  • Prepare responses to questions and potential deficiencies found by the FDA