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Regulatory Affairs Budgets Ramp Up to Reduce Delays and Maximize Submission Success

Study Analyzes Shifting Spending Strategies

RESEARCH TRIANGLE PARK, NC, February 17, 2010 – Regulatory affairs teams’ budgets are increasing at 51% of drug companies, according to new research by Cutting Edge Information (http://www.cuttingedgeinfo.com/regulatory-affairs/).

According to survey data, 94% of companies’ budgets have stayed the same or risen since 2007; of that percentage, approximately half reported a budget increase. Pharmaceutical companies of all sizes, as well as biotech and medical device companies, increased regulatory affairs spending by 18% or more.

Mid-size pharmas, often seeking to further expand their presence in new regions, reported the greatest percentage uptick in spending since 2007, at 39%. For their part, large pharmaceutical companies made a significant increase of their own, adding $4.4 million to an average regulatory affairs outlay of $26.8 million.

These findings are published in “Pharmaceutical and Medical Device Regulatory Affairs,” a new study by Cutting Edge Information, a leading benchmarking research firm for the drug and device industries.

Life sciences companies’ regulatory groups have assumed larger, more strategic roles throughout products’ clinical and commercial development. Corresponding to their elevated strategic profile, regulatory affairs teams find that their budgets are growing at a time when the industry as a whole looks to eliminate costs.

“We’re seeing something of a transformation internally within regulatory affairs,” said Jason Richardson, president of Cutting Edge Information. “Regulatory affairs teams have undergone some sweeping strategic changes. It’s appropriate when you consider that FDA’s recent $4 billion budget proposal includes initiatives to reinforce the agency’s commitment to promoting regulatory science.”

According to Cutting Edge Information’s study, it is critical that companies organize regulatory affairs to encourage greater interaction with a number of internal teams, including clinical development, new product planning and legal to help set a drug’s strategy and ensure its successful submission. At the same time, the project team should aim to engage regulatory bodies as early as possible to open communication lines and create ongoing feedback.

“Pharmaceutical and Medical Device Regulatory Affairs” (http://www.cuttingedgeinfo.com/regulatory-affairs) examines strategies and tactics of more than 50 life sciences companies to empower the regulatory affairs function. It includes regulatory affairs structure models; recommendations for engaging regulatory agencies and improving communications with them; and metrics on regulatory affairs staffing, budgets and outsourcing.

Adam Bianchi
919-433-0202


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