cphi-online.com

The percentage of pharmaceutical companies outsourcing at least part of their regulatory affairs budget has leapt to 68 percent, representing a gigantic increase on figures from 2010 which stood at just five percent.

This is according to a study entitled 'Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy', which found that, while the actual percentage of budgets being outsourced remained low - usually between ten and 20 percent - the number of companies using the tactic had increased dramatically over two years.

"One contract research organisation estimated its dedicated regulatory affairs headcount at 240 full-time equivalents," said Ryan McGuire, research team leader at Cutting Edge Information, which conducted the research.

"Their staff has experience with the regulations regarding global clinical trials," he claimed, adding that some companies may find this expertise in drug development useful.