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.

Download the report on "Growing regulatory's strategic value" for more 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. Total cost of ownership of the technology solution(s) typically includes software licenses and support costs to the technology vendor. Other costs of technology include requirements definition, configuration services, integration services, validation, testing, and training.

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 five-year cost of ownership, which should include five years' worth of ongoing maintenance and support, as well as, on average, one upgrade for existing on-premise solutions. Other costs of implementation and ongoing operation are related to process and governance and are presented in the next section.

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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 process, technology, organization or data, or some combination. To start assessing where to improve, determine if your processes need to be harmonized, whether your employees are proficient in needed competencies, and if your data is in order.

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 in all design, piloting, and implementation efforts. Investing in communications, training, and ongoing support will help ensure successful adoption and sustainment of the changes associated with implementing RIM.

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.

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