Consulting
Expertise: Consulting 223 results
MORRISVILLE, N.C., October 9, 2023 — Premier Consulting, a business unit of Premier Research whose mission is to help the most innovative companies take their best ideas from concept to commercialization, is pleased to announce the appointment of William Bainbridge...
Consulting
Early FDA Feedback with Type D Meetings
What is the Type D meeting? The FDA introduced the Type D Meeting on October 1, 2022, as part of the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter. This new meeting is designed to make it easier and...
Consulting
Abie Ekangaki, Ph.D.
During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. These evaluations include the active pharmaceutical ingredient (API), also known as the drug substance,...
Consulting
William Salminen, Ph.D., DABT, PMP
Premier Research's regulatory strategists specializing in the US FDA’s 505(b)(2) approval pathway are often asked how a sponsor can recover from a pre-IND meeting that doesn’t go as planned. While we firmly believe that setbacks can be turned into opportunities...
Consulting