Case #4 - Turning Around Regulatory Affairs

Situation — The client company's regulatory affairs department lacked clinical expertise and faced significant drug safety questions related to one of its leading products. The department was not respected at the FDA, made poor use of information technology, and was overstaffed.

What We Did — Blair & Company was retained to recruit a new department head capable to lead a complete overhaul of the department. After studying external trends in regulatory affairs and the internal culture of the company, we proposed that the specification for the position be drafted such that it would require an M.D. Our proposal was accepted, and we filled the position with a highly qualified MD. We then consulted with him for more than a year to define and recruit the skills and capabilities needed to complete the turnaround strategy.

Results — Three years later, the department was judged highly effective by its customers. The safety questions regarding the major product had been addressed. The department was highly computerized and operated on a significantly smaller budget.