.png?width=150&name=MMS%20logo_without%20Tagline%20(Full%20Color).png "MMS logo_without Tagline (Full Color)")
Part 2: 505(b)(2) NDA – The Importance Early-Stage Planning
by Ben Kaspar, Director of Regulatory Affairs
Part 1: 505(b)(2) NDA – Navigating the Regulatory Pathway
by Ben Kaspar, Director of Regulatory Affairs
FREE DOWNLOAD: Lay Summary Whitepaper
This complimentary lay summary whitepaper will explain:
Regulatory Strategy, 505(b)(2) Applications, and Chess: A Conversation with Ben Kaspar
In this Expert Insights interview, we sit down with Ben Kaspar, Global Submissions Manager at MMS, to discuss ...
Safety Writing, REMS, and Regulatory Requirements: A Conversation with Jeffrey Wiese
In this Expert Insights interview, we sit down with Jeffrey Wiese, Manager of Safety Writing at MMS – to ...
Tips for Nonclinical Pharmacology and the Medical Writers that Draft Regulatory Submissions
by September Mihaly, Ph.D., RAC
Writing for Regulatory Agencies vs. Medical Journals: The Differences
by Megan Day, AA, BA, PhD (ABD)
Medical writing: Its future, people, and processes
by Teresa Ceseña, Senior Director or Regulatory and Medical Writing
Four initiatives to combat the opioid epidemic
by Jeffrey Wiese and Julie Legakis
The Ultimate Lay Reviewer Checklist for Lay Summaries
Lay review is an essential step in the plain language summary (PLS) writing process. The reason being that it ...
Navigating the four types of clinical study reports
A Clinical Study Reports (CSRs) are critical documents that describe the methodology and results of a ...