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
For more information about regulatory affairs or pharmaceutical
compliance benchmarking, contact Cassie Demeter at (919) 403-6583.
[ Back To NFVZone's Homepage ]