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Growing regulatory’s strategic value
The value of a holistic regulatory information management (RIM) capability
Regulatory functions within a life sciences company can be complex and challenging to optimize. Using a holistic RIM capability can offer numerous financial and operational benefits. In addition to implementing RIM technology, companies must also address organizational, data, and process dimensions to fully realize the potential of a comprehensive RIM solution.
- Understanding the regulatory ecosystem
- Investing in RIM
- Next steps
- Join the conversation
- Related topics
Understanding the regulatory ecosystem
Regulatory functional groups (for example, regulatory affairs/operations or lifecycle management) are part of the critical path to new product launches, and directly enable continued access to marketed drug products. Regulatory teams can help speed time to market through innovative registration strategies as well as effective submissions development processes.
Regulatory also plays a key role in maintaining patient access to products and optimizing profitability through effective lifecycle maintenance. The business case for leading-class regulatory capabilities should, therefore, aim to maximize revenue and minimize compliance and quality costs, rather than simply focus on process efficiency.
Regulatory reporting requirements and business financial imperatives are reshaping regulatory from a largely document-based paradigm to a data-based paradigm. Managing structured and unstructured content, as well as a wealth of metadata, demands a new level of precision in executing regulatory responsibilities. As a result, the industry must address multiple challenges that, in aggregate, make it difficult to achieve full regulatory process continuity and a comprehensive view of regulatory information.
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Investing in RIM
Of course, achieving significant returns on effective implementation of RIM requires an initial investment. The costs associated with technology solutions can be significant, especially if companies are maintaining several point solutions.
Some solutions may require considerable investment in infrastructure, especially if implementing multiple, on-premise point solutions. Identity and access management, back-up and recovery solutions, and technical support should also be figured into calculations. Many companies under-invest in organizational design and change management. Often, aligning stakeholders to a common process and technology involves addressing multiple value propositions and effectively communicating the rationale and benefits associated with the intended changes.
Companies often look at
Next steps to grow regulatory's strategic value
Understanding current state
It is important to objectively evaluate your current capability maturity and pinpoint areas that are deficient. The resolution may be related to
Organizational change management
Implementing an effective solution, however attractive to leadership and to users, involves substantial change. It has been said that "culture trumps strategy," but changing attitudes and behaviors is not simple. Organizational change management should be integrated
Defining your roadmap
Your roadmap to realizing the value from RIM must reflect understanding of current state, interdependencies, and the target business priorities and expected benefits. Companies should plan, and budget for, non-technology activities such as process and data as part of a RIM program. Prioritize those capabilities that will provide the greatest return on investment and implement iteratively, capability by capability, even if pursuing a unified platform solution. It usually makes sense to pick a high-value yet achievable capability area rather than trying to create a big bang. Most importantly, communicate sufficiently to identify and align stakeholders because many will be impacted—all for the better.