Publication / Source: Bioanalysis 3(3)
Authors: Arnold EM
“…a growing challenge of the past decade has been additional country-specific and regional regulations…”
Providing a single set of standard operating procedures for method validation and sample analysis that meet the requirements of multiple countries is becoming a growing challenge to bioanalytical groups supporting the development of new drugs intended for global use. Over the past 20 years, pharmaceutical companies are seeing the need to change from a USA–Canada–EU–Japan primary focus for their new drug applications to one that includes other countries and regions with emerging markets and growing demand [1,2]. To survive in today’s market requires companies to understand not only the market pressures in each country, but also the regulations.