37 Centigrades AG supports in the definition of a RIM scope that matches a company´s needs, may it be for a mutlinational corporation or a player of different size and reach. Dependent on strategic ambitions such as correctness of information, timeliness, or short cycle times that function as drivers and anchor, a RIM vision can be derived and lined up for future implementation. These future states might pursue different degrees of integration with other relevant information sources, for instance the document and submission management platforms, change management system, questions and answers systems, country requirements systems, or archiving solution to name a few. Balancing out efforts and benefits on the short-, mid-, and long-term perspective can then provide a plan on how to transform the IT and business process landscape.
Subject Matter Emphasis - Regulatory Affairs & RIM Advisory and Consulting
Companies operating in the life science industry need market authorization in order to establish and maintain the basis of activity. The regulatory affairs departments take care of these matters. Dependent on a corporation´s size and operating model, information generated and disseminated internally or externally must be managed. Even more importantly, coordination and combination of all relevant information pieces shall lead to an elevated state, where data can be used to drive data. Definition of understanding and scope what shall be considered regulatory information and what shall be managed how is a pre-requisite for success.
