Automation is a definite help to Regulatory Affairs. But they need "smart" automation and not routine task automation.
Online PR News – 21-December-2016 – New Jersey – The regulatory landscape is fast changing with the advent of modern technologies supporting companies in understanding disease patterns, addressing customer needs by bringing in customized therapies. The challenging landscape is largely a result of increase disease burden, new disease areas, ageing population and ever increasing R&D costs. In addition, business competition has forced bio pharmaceutical companies to expand their frontiers to attain global reach, launching their products in many regions and countries, and therefore exposed to myriad, and sometimes diverse, regulatory requirements and operating standards.
Regulatory Affairs play key role in all these areas. Though a matured discipline in the industry, majority of the daily questions Reg Affairs teams need answers are situation or context based. Reading several 100s of pages of new guidelines or regulations is not practical anymore because of time pressures and also stagnant RA budgets. They need answers that are customized to their situation on hand or relevant to their products and countries. From various Health authority sites, the can get lot of information which they need to synthesize and arrive at conclusions which again demands time. Hence MakroCare developed platform utilizing Artificial Intelligence called as RegAI.