As an increasing number of pharmaceutical and device developers focus their efforts on reducing costs so they can invest more heavily in their core R&D functions, it’s no surprise that the outsourcing market for healthcare regulatory affairs is predicted to expand at a rapid pace over the next decade. Some estimates predict the market will reach $200 million by the end of 2025.
As the number of contract research organizations (CROs), contract medical organizations (CMOs) and other new regulatory affairs outsourcing options expands, the process of choosing the right regulatory affairs partner grows more complex and challenging for pharmaceutical and medical device developers.
Yet, in my three decades of experience working in this industry, I’ve seen first-hand the critical role that regulatory affairs can play in expediting a successful approval for a drug or device’s development – or stopping it dead in its tracks. Delays in a product’s path to regulatory approval aren’t just costly to developers— they’re also costly to patients, whose health and well-being may be dependent on these new therapies.
If you’re planning to outsource your product’s regulatory affairs or regulatory writing work, here are four keys to help you choose wisely:
As drug and device developers focus on cultivating their own internal R&D talent and expertise, they’ll continue to seek out regulatory affairs experts who can help them contain costs while expediting their paths to approval. However, choosing the right outsourcing partner, from the start, is key to the success of this approach. Sponsors must be thoughtful and strategic in engaging early with partners who have not just the therapeutic and pathway approval experience, but also the depth and breadth of experience needed to anticipate and remove potential roadblocks and accelerate the approval process.