Greg Onyszchuk, Ph.D.

Greg Onyszchuk, Ph.D. is with Beckloff Associates, Inc.

United States federal laws make mandatory the registration of drug establishments, including both domestic and foreign, and the submission of drug listing information to FDA. Effective June 1, 2009, there are important changes to the requirements – and these changes apply to every company that has a drug establishment registration or drug listing with FDA. Your immediate action is required.

Pharmaceutical and biotech sponsor organizations are in increasing numbers making the switch from paper to electronic format for their marketing applications to FDA. The decision to adopt the electronic Common Technical Document (eCTD) submission format is a strategic one, offering the sponsor many important benefits. Given the current difficult economic environment, sponsors, especially those with modest submission volumes, should give strong consideration to outsourcing as an option that can enable the strategic benefits of eCTD while significantly reducing the barriers.