Regulatory Information Management: Making the Business Case for RIM Transformation
Patterson Shafer, Life Sciences Specialist Leader, Deloitte Consulting LLP
Regulatory Affairs teams can be instrumental in speeding time to market through innovative registration strategies as well as effective submissions development. Regulatory also plays a key role in maintaining patient access to products and optimizing profitability through effective lifecycle management. The business case for leading-class regulatory capabilities should therefore be focused on maximizing revenue and minimizing compliance and quality costs, rather than simply focusing on process efficiency.
Value reflects the balance between costs and benefits. Investment in an effective RIM solution involves not only the RIM technology, but process, organizational change, and data management elements. However, investing in the regulatory function, if made appropriately, could return substantial benefits in cost avoidance and improved financial performance.
Previous challenges defining the business case for RIM are due in part to how the scope of change radically effects the financial impact. Any single RIM capability will likely have a proportionally smaller impact if changed independently rather than as part of a broader initiative. Due to the complexity of regulatory processes, particularly in multi-national companies, taking a unified approach will likely deliver returns far greater than the sum of smaller, isolated initiatives. Below are a few of the potential benefits from a unified approach to RIM:
When making the business case for RIM transformation, companies should plan, and budget for, non-technology activities such as process re-engineering and data governance initiatives. It has been said that “culture trumps strategy;” as such, changing attitudes and behaviors is no simple effort. Organizational Change Management should be integrated in all design, piloting, and implementation efforts. Investing in communications, training, and ongoing support can help ensure successful adoption and sustainment of the changes associated with implementing RIM.