ABSTRACT
Regulatory affairs (RA) over the last two decades has played an ever-increasing role in the development of new medicinal products with the average development program, from inception of an idea through to market, taking between 12 to 15 years. The estimated expenditure by pharmaceutical companies over this period and before any cost can be recovered is currently between $500 (£350) million and $800 (£500) million for a new chemical entity.
