Insight on What Matters - So You Can Transform Your Business.
As of May 5, 2017 submission of NDAs, ANDAs and BLAs to the Center for Drug Evaluation and Research (CDER) using the eCTD format became mandatory. For commercial INDs and Master Files the deadline is May 5, 2018.
At ShareVault we’ve facilitated thousands of acquisitions worth billions of dollars, and we’ve learned a few things, such as the following.
We’ve identified eight areas of focus that facilitate a healthy and transparent relationship between CEOs and their board. It’s all about communication.
In the process of finding a partner and negotiating an agreement, a central question arises: What is my drug candidate worth?
When conducting due diligence on a target company, your goal is to thoroughly evaluate its affairs in order to make an informed decision as to whether to proceed with an acquisition.
Maren Nelson has developed multiple medical devices during her career. Her projects have included internal and external resources for both the development and manufacturing of new products and product changes. Maren currently consults on medical product development strategy and Quality Management System implementation and improvements.
ShareVault, a virtual data room provider, is proud to announce that we have recently been awarded two prestigious awards from FinancesOnline: the Rising Star Award for 2017 and the Great User Experience Award.
In 2016, the FDA’s Center for Drug Evaluation and Research (CDER) approved just 22 novel drugs. This is in comparison to 41 and 45 in 2014 and 2015 respectively.
For the last eleven years the Ponemon Institute has conducted a cost impact security study of data breaches on organizations worldwide. The latest study, done in partnership with IBM Security, published in 2016, reports on data breaches in 383 organizations across 16 industries and in 12 different countries.
As a prelude to the web panel discussion, we sat down with John Hotta to find out what he believes are the major pitfalls and best practices for M&A due diligence and integration.
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