YourEncore, which helps life sciences, consumer products and food companies solve complex innovation, compliance and productivity challenges, has launched the Regulatory Center of Excellence, to provide life sciences companies with industry-accomplished experts to guide them through complex regulatory requirements, from phase I trials through approval.
The pharmaceutical market is becoming more heavily regulated, and the cost to life sciences companies for drugs that fail during the regulatory phase is skyrocketing. According to a Datamonitor study that analyzed 346 new drug applications over a four-year period, 42% received a complete response letter (CRL), which resulted in a median delay in approval of 13 months.
“These delays are very expensive to life sciences companies, and often they can be avoided,” said Tim Franson, M.D., YourEncore’s chief medical officer. “YourEncore’s regulatory experts have extensive therapeutic expertise in classic regulatory issues and have proven experience getting major drug and device approvals.”
YourEncore has provided regulatory guidance to life sciences companies since its founding in 2003. The Center of Excellence will further expand the depth and breadth of available expertise, giving clients quicker access to a database of ready experts for targeted, customized solutions.
The center is led by Carol Stephens, who has more than 25 years of experience in the pharmaceutical industry, including recent roles in regulatory affairs at Eli Lilly.