Catalent Forms Quality, Product Development & Regulatory Affairs Organization

Catalent Pharma Solutions has established a new Quality, Product Development & Regulatory Affairs organization, which will focus on partnering with customers as part of its New Product Introduction Excellence program. The company says the program is an important part of its growth strategy, which has expanded at a rate of more than 70% over the past three years, from 59 new product launches globally in 2012, to 97 in 2013, and 175 in 2014.

Sharon Johnson, senior vice president, global quality and regulatory affairs, will head up the new organization. Ms. Johnson will oversee a global function that includes more than 1,500 scientists, quality and regulatory affairs professionals. Previously, she served as Catalent’s senior vice president, global quality and regulatory affairs overseeing the rollout of Catalent’s global quality management system to more than 20 global sites. Ms. Johnson has 30 years of experience in the pharmaceutical industry, including API and multiple dosages forms, from discovery and launch of NCEs and life cycle management.

“The overall goal of the Quality, Product Development & Regulatory Affairs organization will be to drive excellence and reliability across all of the products that we make and deliver,” said Ms. Johnson. “Our customer promise is not only to provide a reliable supply of their current, ongoing products, but to deliver new products with the same rigorous commitment to excellence. Bringing together these two functions into one team will tighten collaboration and the partnerships across the organization which are needed to bring more new, innovative and life-saving products to market quicker.”