A majority of surveyed pharmaceutical companies outsource at least part of their regulatory affairs budget. This is up 5% from 2010, demonstrating that fewer drug companies are trying to keep such activities entirely in-house than before, according to a recent study by Cutting Edge Information. The study, “Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy,” found that the industry is beginning to find benefit in hiring experienced contractors for many regulatory affairs tasks. The percentage of budgets being outsourced remains low—usually hovering between 10% and 20%, with a few outliers hiring vendors to perform more tasks than most companies tend to.
All surveyed Top 20 pharmaceutical companies reported outsourcing at approximately 10% of the overall regulatory affairs budget. Tasks that Top 20 companies outsourced included publishing, labeling or tracking changes to regulatory guidelines. Most companies also use vendors for post-market surveillance tasks, preferring to keep products that are still in development more close to the vest. However, contract research organizations (CROs) that Cutting Edge Information interviewed championed their ability to give investigational products the attention they deserve, despite drug manufacturers’ doubts.
“One CRO estimated its dedicated regulatory affairs headcount at 240 full-time equivalents (FTEs),” said Ryan McGuire, research team leader at Cutting Edge Information. “Their staff has experience with the regulations regarding global clinical trials. For some companies, it may be worth using this expertise during drug development.”
“Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy” (http://www.cuttingedgeinfo.com/research/regulatory/market-approval/) contains resource benchmarks, strategic recommendations and best practices for building a strong regulatory affairs team and improving regulatory submission timelines. The study also delves into the topic further to find which regulatory functions companies commonly outsource, how much money they divert to them and why.
It is designed to guide key decision-makers to:
• Overcome hurdles in your regulatory process to move your products to market as soon as possible.
• Position regulatory affairs at the center of strategic activity.
• Benchmark the most desired skills for regulatory affairs employees and hire accordingly.