by Prakash Achaary | Feb 14, 2019 | Blog
In this Expert Insights interview, we sit down with Ben Kaspar, Global Submissions Manager at MMS, to discuss regulatory strategy, 505(b)(2) applications, and general submission advice for any global companies outside of the US that plan to submit to the FDA. In...
by Prakash Achaary | Jan 10, 2019 | Blog
Approximately 90 percent of global pharmaceutical companies are using, or have plans to use real world data in the near future, according to a 2018 benchmarking survey from Deloitte. This coincides with an increased focus on the use of real world evidence from the...
by Prakash Achaary | Oct 25, 2018 | Blog
This article was drafted based on a presentation given at the 9th Annual Scientific Symposium presented at MMS global headquarters in Canton, Mich. Opioid use in the U.S. is widespread. Last year, there were 58 opioid prescriptions filled for every 100 U.S. citizens,...
by Prakash Achaary | Oct 4, 2018 | Blog
Regulations in the pharmaceutical and biotech industry are constantly evolving. Staying informed of all updates and navigating changes internally is a monumental task. To learn how MMS experts traverse these waters, we connect with Amanda Beaster, Ph.D., Technical...
by Prakash Achaary | Sep 6, 2018 | Blog
A Clinical Study Reports (CSRs) are critical documents that describe the methodology and results of a clinical trial in drug development. As of late, CSRs have been reviewed under a higher level of scrutiny as the U.S. Food & Drug Administration (FDA) announced a...
