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 BPCA and PREA needs. This paper is meant to serve as a review and primer for anyone at the Pre-IND stage or who is confronted with the need…