An organization’s ability to learn and translate that learning into action rapidly is the ultimate competitive advantage.
- Jack Welch, business leader, chemical engineer, writer and former Chairman and CEO of General Electric
Real Time Regulatory Intelligence
Smart regulatory processes and regulatory intelligence have evolved over past decade. Human race has finally transferred its knowledge and experience to machines for smart processing. Automation of processes, use of AI & ML have gained a lot of traction and are now the new competitive battleground. Technology is keeping pace with the rapidly changing regulatory environment. Thus, advanced automated solutions are the immediate need. Over the years, DDReg has maintained strong reference base to global regulatory regulations – country & region wise. This has helped to stay updated with global regulatory updates. Its front end engagement mechanisms like Scientific Advisory Meetings (SAMs) and direct communications with agencies has helped gain immense regulatory intelligence which helps in developing strategies for success in markets with speed.
Regulatory function is the critical to generate revenue windfall from a product. An on-time or before time grant of a Marketing Authorization invariably is a result of right regulatory strategies. Thus, efficient management of projects from a regulatory perspective are invaluable for successful product launches and hence speed to market. Use of technology to combine end-to-end planning, coordination, execution of regulatory procedures and submissions has significantly shortened the regulatory project timelines. Automation has brought advantages like cost efficiencies, higher productivity, informed decision making and speed to market. DDReg’s regulatory processes to obtain Market authorization for biosimilars and generic pharmaceuticals in complex markets is well established and has been well recognized by its global customers. These processes have been optimized and automated to a regulatory lifecycle management solution that helps DDReg teams in Planning, Tracking, Document Management, Product Registration, Submission Publishing & Lifecycle Management. The in-house solution is a versatile system for keeping track of all project/product information and managing all regulatory activities in the pharmaceutical product life cycle.