The submission management needs of companies vary significantly, particularly when it comes to size of the company. Deciding to work with a business process services (BPS) partner to implement agile workload management practices, therefore, should take those different requirements into account.
By Marcy Miller, Principal, Regulatory Solutions and Services, CSC
A small company with few products on the market would not necessarily have the software toolsets needed for managing its Investigational New Drug (IND) applications or New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs). Working with a BPS partner that has the tools a company might need, or the resources to manage those processes on your behalf, would make good business sense. That would allow a small company with limited resources to pay a monthly fee for a service rather than procure the technology — an expense such a company could ill afford before they have a product on the market.
The tools and the resources to use those tools are just part of the story. The other part is having access to regulatory affairs intelligence as you navigate the complex process of bringing a new chemical compound, biologic or even an orphan drug to the market.
Part of the Team
When it comes to more established midsize or large pharma companies, the real benefit with a BPS engagement lies in the partnership that develops. (See, for example, How “Them and Us” Becomes “We”: Behind the Scenes in a BPS Partnership, a September 2016 blog by Anthony Szaro, CSC Life Sciences.)
A BPS partner can become part of your team, working in your environment to provide support for peak periods, as well as providing consulting expertise if you’re moving into a new therapeutic category or if you’re a small molecule-focused company making a first foray into the burgeoning area of biosimilars. A BPS partner can help you understand what the U.S. Food and Drug Administration’s (FDA) requirements are when filing a biosimilar, as compared with its requirements when dealing with a pharmaceutical product.
Your partner could also set up and run your entire regulatory program for you. For example, perhaps you’re going through a change in business strategy and have an opportunity to acquire a new line that will help you to grow, but you don’t have the time to bring the right people on board. Having a BPS partnership can give you access to an entire team of experts to manage that process on your behalf and enable you to bring a new class of products into your portfolio.
There are also the more day-to-day needs that global companies have. For example, there might be changes to how a company’s product needs to be filed with the European Medicines Agency (EMA), or another regulatory authority has begun requiring electronic Common Technical Document (eCTD) submissions. Knowing what those requirements are and how they affect your marketing authorizations is crucial. A prime example of this is the FDA’s requirements that as of May 2017 all NDAs, ANDAs and BLAs must be submitted in the eCTD format.
Other complex requirements that companies often struggle with relate to the Clinical Data Interchange Standards Consortium (CDISC) data format. Knowing what is required of you, and when and how to convert the data to the proper format involves very specific knowledge, and having a BPS partner with this level of expertise simplifies the journey. Filing your study data in the correct Study Data Tabulation Model (SDTM) format will ensure that the FDA reviews your application more rapidly, which is a priority for all companies regardless of size.
Another advantage of working with an experienced BPS partner is that you learn from the experience of other companies and so are able to adopt best practices. This is important not just for the business but for regulatory professionals such as you. Being able to lead your organization or function with practices that ensure you are not only relevant but essential to the business can make all the difference in a highly competitive environment.
For regulatory professionals, it’s about ensuring that you and your colleagues are relevant to the business as a whole, and that you are able to speed the submission process through innovative practices that ultimately will help your product get to market quicker.
Join us at CSC’s Executive Dinner and Thought Leadership Panel Discussion in Bridgewater, New Jersey, on March 2, 2017, to gain insights from industry thought leaders as well as to network and share best practices with your peers in a relaxed dinner discussion.