Epista Life Science is proud to announce our inclusion as one of the service vendors in the 2022 in the Gartner Market Guide for Life Science Regulatory Information Management Solutions report (1).
The 2022 Market Guide lists three recommendations for “Life Science CIOs advancing healthcare and life science digital optimization and modernization.”
Life Science companies should first, “Select potential RIM vendors by assessing them based on their strengths, weaknesses, cultural fit and overall reliability as your business partner.” Second, “Evaluate regulatory solutions by performing a thorough RFP process involving business leaders that covers breadth and depth of the solution, cost of upkeep, licensing and hosting options, and roadmap for future expansion.” And third, “Future-proof regulatory capability by seeking vendors that enable ready integration with neighboring systems in manufacturing, supply chain, finance and quality departments to create a more holistic regulatory solution suite.”
According to this report, “Global life science companies face continuous business pressures to grow their products and expand into new markets. Yet, regulatory teams find it increasingly challenging to keep up with shifting regulatory requirements — such as updated Identification of Medicinal Products (IDMP) guidance — and maintain compliance with changing local rules and regulations.”
Klavs Esbjerg, Epista Life Science CEO, is very pleased to be mentioned by Gartner in this report. “Compliance requirements protect the public, but also create challenges for every aspect of Life Science, from R&D to production and success in the market. These requirements are always evolving, and so are the technologies that can address them. Regulatory Affairs is a highly complex domain and an integral part of any Life Science company. Epista’s Regulatory Team has deep knowledge and understanding of the regulatory requirements – like IDMP – as well as extensive experience with the related IT systems, allowing them to turn clients’ obstacles into business opportunities and help increase the contribution of Life Science to society.”
Gartner members can access the full report here.
If you’re looking to address the complexity of the Life Science industry’s compliance requirements, we’re ready to help. Read more about our expertise here.
1. Gartner,“Market Guide for Life Science Regulatory Information Management Solutions,” byRohan Sinha & Jeff Smith, 4 April 2021.
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