K2 Consulting is proud to announce our Strategic Alliance with Gens & Associates. Learn more
K2 Consulting provides expertise in Regulatory and Compliance business processes and systems, IDMP/SPOR, and Regulatory Information Management. View our Services
Strategy & Vendor Selection
Your technology strategy should be aligned to your business strategy. K2 can guide you through a roadmapping and system/vendor selection process to ensure you make the right choice for your company’s future.
Project Management
K2 can manage your project or provide support services to your internal SME team to ensure your project is successful
Expert Facilitation
Leverage K2’s expert facilitation to support your process mapping, requirements definition, system design, vendor evaluation, and other workshops. Our facilitation process supports your existing expertise to ensure valuable results.
IDMP/SPOR
We are actively participating in standards development and implementation activities. Leverage K2’s expertise to support your planning and implementation.
Kelly Hnat
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)
Contact us to find out how we can help you reach your goals
