DURHAM, N.C., JULY 30, 2018 — Premier Research, a global provider of clinical development services to biopharmaceutical product innovators, has acquired Regulatory Professionals, Inc. (RPI), a California-based company that provides regulatory expertise and solutions to biotechnology, pharmaceutical, and medical device...
Expertise: Consulting 214 results
The overarching goal of the Special Protocol Assessment Draft Guidance for Industry May 2016 (HHS, FDA, CDER, & CBER) is to improve the quality of new drug applications (NDAs) and biologic license applications (BLAs) by providing more certainty in the clinical protocol...
A significant part of the FDA’s charge is ensuring the safety of drugs available to the public. While a substantial part of the FDA’s efforts in guaranteeing public safety go into the safety assessment process during drug development, the process...