Articles by Greg Onyszchuk, Ph.D. - Pharmaceutical Technology

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Articles by Greg Onyszchuk, Ph.D.

Greg Onyszchuk, Ph.D.


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

Articles
Preparing for Mandatory Electronic Submission of Drug Establishment Registration and Drug Listing Information
August 1, 2010

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.

Outsourcing: A Rapid, Cost-Effective Option for Electronic Submissions
August 1, 2010

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.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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