With over 20 years of experience in working alongside global agencies, DDReg has maintained a robust reference base to global regulatory regulations and has stayed updated with the everchanging regulations while providing end-to-end regulatory services. Front-end engagement mechanisms such as Scientific Advisory Meetings and direct communications with agencies has helped acquire immense regulatory intelligence. This is advantageous in developing the right strategies for on-time or before time grant of Marketing Authorization which will subsequently help achieve rapid market success.
RegTech focuses on technologies that may facilitate the delivery of regulatory requirements more efficiently and effectively than existing capabilities. The global adoption of RegTech is a result of increased regulatory scrutiny, compliance costs, development of artificial intelligence, evolution of data science and increasing demands regarding cost-effective compliance solutions. With ever changing regulatory requirements, pharmaceutical organizations face many compliance challenges due to increased stringency.
Advanced, automated regulatory solutions are in need.
Technology is exploited to merge end-to-end planning, coordination, execution of regulatory procedures and submissions together to shorten the regulatory project timelines. Automation of these processes leads to cost efficiencies, higher productivity, informed decision making and speed to market.
On a global level, DDReg is recognized for their regulatory processes in obtaining successful market authorization for generic pharmaceuticals and biosimilars. DDReg’s in-house tool allows the automation of such processes for regulatory lifecycle management and keeps track of products, projects, and their related information.
DDReg’s RegTech space will invariably enable organizations to achieve rapid market access. Get in touch with us to find out more.
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