Download our Latest Paper: Help With BPCA, PREA, Initial Pediatric Study Plans (iPSP), Deferral and Waiver Requests

As pharmaceutical consultants engaged in the compilation and submission of marketing applications, we are frequently called upon by our clients to address all or part of their Best Pharmaceutical for Children Act (BPCA) and Pediatric Research Equity Act (PREA) needs. This paper is meant to serve as a review and primer for anyone at Pre-IND stage or who is confronted with the need for help with an iPSP, including a waiver or deferral request. Click here to read the paper or here for help with your iPSP.