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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

  • Search
  • Suppliers
  • Careers

Enter a company or product name

Keyword Location
About Search
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.

ADVERTISEMENT

LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
FindPharma Custom Search
Click here