Four(4) Themes for Innovation in Regulatory Affairs

Innovation is something that all organizations strive for with the belief that it will drive value creation and market sustenance. Life Sciences industry is built on innovation, in a way, in terms of their constant search for new drugs, devices and cures. Technology has become ubiquitous in driving not only scientific innovation in terms of discovering and marketing new treatments, but also in building, integrating and managing platforms that support the scientific innovation.

Regulatory Affairs, to me, is one function that does not get as much credit and focus as some of the more popular ones like Discovery, Clinical, Safety, Sales & Marketing. Yet, that is the function that could make or break the launch of a successful product and even more to ensure that product stays in the market to realize its full potential. Many activities performed in regulatory are operational in nature and deals quite a bit with managing content i.e. documents. With the advent of regulations like IDMP, EU MDR etc. many companies are realizing the need for mastering and harmonization of data across the functions to be able to reign in the silos built over decades. This is where I feel leveraging some of the technology innovations will make Regulatory Affairs more efficient, reduce the risk of non-compliance and truly deliver the returns expected from the investment.

Key to building and managing a successful Regulatory Affairs organization, in my opinion, is to deliver on the following objectives:

1. Continued Regulatory Compliance: Meet ever changing regulatory needs
2. Technology Currency: Ensure the systems and platforms are always current in terms of technology used
3. Operational Excellence: Always look for improvement in operations to ensure successful delivery despite dwindling budgets and increasing demands and
4. Faster time to Market: Drive faster regulatory approvals and life cycle maintenance activities to maximize the product potential in the marketplace

From an innovation standpoint, four (4) themes that can help achieve these objectives are:

1. Digitization of Content: Ability to create, manage and obtain insights from content leveraging digital tools & technologies
2. Business Process Efficiencies: Achieving efficiencies through optimized orchestration of end-to-end business processes across functions
3. Cross-Functional System Integration: Integration of systems across functions like Manufacturing, Regulatory Affairs, Safety & Pharmacovigilance, Commercial etc. to better leverage data and content
4. Technology Innovation: Leverage technological advances like RPA, AI, ML, Blockchain etc. to innovate Regulatory Affairs

While these themes/levers are good to use on “what” can be done, it is critical that we also identify “where” these can be leveraged. What would be even more useful is to identify these use cases within a given function of Regulatory Affairs, like Labeling Management. My next post will address this aspect.