Combination Products

The market for combination products is continually expanding, and consequently, their manufacture continues to raise challenges. This text provides an overview of the process from start to finish, complete with relevant definitions, and then shows how to establish a design and development plan. It provides an overview of FDA and other regulatory expectations and covers resource requirements, manufacturing, pitfalls, post-launch compliance requirements, and agency audits and challenges. The book presents practical guidelines on how to develop combination products successfully and how to implement them into the market successfully and in a timely manner.

Auteur

Smita Gopalaswamy, Venky Gopalaswamy