The regulatory submission process can be an enormous challenge for many life sciences companies, particularly mid-tier and smaller companies. Managing different types of submissions or various regional requirements exacerbate the difficulties faced.
By Leslie Wan, Global Head, Regulatory Engagement Management, CSC
After years of commitment and investment to take a product through research and development, a company’s know-how, expertise and capital are typically invested in its core competencies – the science and product marketing – and not in dossier management and submission.
Understanding and responding to various regional regulatory requirements – be it the U.S. Food and Drug Administration, the European Medicines Agency or any number of other regulatory authorities – calls for investment in experienced personnel, publishing software and other technologies, as well as knowledge of best practices. That’s a big stretch for a small or mid-tier company, particularly if they haven’t begun recouping the investment they’ve made in their product.
It’s often at this point that life sciences companies turn to a Business Process Services (BPS) vendor with strong industry expertise, ideally a vendor that has years of experience managing regulatory submissions. For life sciences companies without submission experience, going it alone can result in potential missteps which can delay the submission, slowing time to market and ability to start generating revenue. Typically, the BPS vendor will be managing regulatory submissions day in and day out, enabling them to develop best practices.
So where does the outsourcing submission journey begin?
Without the resources in-house, smaller and mid-sized companies are often tasked with doing more with less, or even getting a submission out with little or no in-house expertise or internal technology solutions. In that case, the company may elect to shift all submission activities to their BPS vendor, at least at the start.
If the arrangement suits the company – perhaps it needs to stay lean for a future acquisition or it has diversified away from all regulatory operations activities – the full submission outsourcing approach may continue indefinitely.
For others, assuming they have established a long-term engagement, the relationship might start to evolve. Perhaps they start by employing one or two regulatory operations experts to manage part of the submission journey or to handle one key product in a specific market, while the BPS vendor manages the portfolio of active applications. The benefit is the company gains experience and product oversight while still enjoying agile workload management from their vendor.
The next phase of the journey might be to bring technology in-house, for example an internal software-as-a-service solution and another couple of regulatory operations professionals to support the growing portfolio. As the company starts to operationalize business change, the BPS vendor remains a constant, trusted partner to support the technology, the internal staff and the submission, and to continue to manage the life cycle of marketed products.
At any point in the journey, a company can choose to scale up or scale down BPS support, while knowing they have the flexibility to respond to submission requirements in any market by leveraging their partner. BPS is a journey of the life sciences company’s making, adapted to current and future needs.
CSC Webinar: Business Process Services – Strategic Enabler for Quality Regulatory Submissions, October 19, 2016. Learn more about CSC’s Business Process Services and how one mid-tier life sciences company began and adapted its journey.