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ABOUT US |
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Submission Consulting Group (SCG) was founded in 2005 to provide services to the life sciences industry. SCG works closely with companies and regulatory agencies worldwide.
SCG has built a strong reputation as a leader in electronic regulatory submissions. We have extensive, recent experience with not just the FDA but also regulatory agencies in Canada, Europe, Australia and New Zealand.
West coast based with East coast staff as well, often working around the clock to meet critical deadlines, SCGs team of professionals provide a comprehensive set of document management and regulatory publishing services to the life sciences industry.
Jeff Wilson is an experienced professional who has helped many companies produce INDs, new drug and biologic applications for submission to health authorities worldwide. Jeff started working in electronic publishing in 1981 for the defense industry preparing technical documentation for state-of-the-art weapons systems. Jeff has worked with pharmaceutical and biotech companies since 1999 assisting in the implementation of regulatory publishing and document management systems. Jeff has first-hand submission publishing experience with all the major providers of eCTD publishing solutions.
Connie Yim began working with the largest biotech in northern California in 1993. She worked in a number of different departments and for several biotechs before joining SCG in 2007. Her areas of expertise are document publishing and formatting; records management and document management systems.
Dan Offringa has a regulatory career spanning close to 30 years. For the last 16 of those he has been active in the electronic submissions field for both FDA and industry, including work on guidance promulgation, standards and process development, and systems implementation. He has been responsible for the publishing of many INDs, Master Files and marketing applications, with submissions to multiple
regulatory authorities.
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