The business environment for Life Science companies is becoming more demanding and complex. Increased scrutiny from Governments and Regulatory Agencies, changing business models (mergers, acquisitions, globalization, and outsourcing) and mounting price pressures are forcing companies to focus on productivity across all functions.
Historically, Regulatory Affairs (RA) has not been a primary focus area for operational efficiency programs, however, this is changing. With the need to reduce drug approval cycle times and regulatory standards like IDMP, all eyes are now turning toward RA to operate in a faster, more efficient and, compliant way. This whitepaper will examine how Regulatory Information Management (RIM) is being seen more and more as a strategic component of the business to overcome regulatory challenges.