by Avery Zimmerman | Jan 4, 2023 | Blog
The Clinical Trials Information System (CTIS) is a single portal for European Union (EU) competent authority and ethics submissions for clinical trial applications (CTAs) across EU member states. The system represents the actualization of the EU Clinical Trials...
by Avery Zimmerman | Jun 13, 2019 | Blog
New and updated regulatory guidances from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and other global health authorities are continually being release. These guidances are...
by Avery Zimmerman | Jun 6, 2019 | Blog
SOUL stands for bringing a Sense Of Urgency and Leadership to work each day. The SOUL of MMS comes to life as project work is completed on time and as risks and solutions are identified proactively. At MMS, each colleague takes responsibility for the success of every...
by Avery Zimmerman | May 23, 2019 | Blog
The unique aspects of the 505(b)(2) submission structure and label claims are perhaps best illustrated at the pre-IND planning stage. Whereas for a new chemical entity, pre-IND discussion is generally focused on the determination of a safe starting dose in humans, the...
by Avery Zimmerman | 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...
