K2 provides expertise in Regulatory and Compliance business processes, IDMP/SPOR, and Regulatory Information Management.
K2’s mission is to help pharmaceutical companies identify and implement the most effective processes and systems to manage their regulatory data with confidence and compliance, so it can be relied on to meet all their business and regulatory requirements.
We can help you master your data through process-focused management. Contact us to find out how.
Kelly is a recognized industry leader in RIM and IDMP with over 20 years experience in the pharmaceutical industry, the last 11 focused on Regulatory Affairs. She has led both IT and RIM/Reg Ops organizations in several companies and has overseen implementation of large-scale global systems and processes. Kelly is passionate about the possibilities for pharma companies to improve productivity and compliance through process-focused management of critical data. She is an industry leader on the EMA SPOR Task Force and its PMS subteam and is also involved in ISO TC/215.
Kelly is also Vice President of IRISS (www.iriss-forum.org)