INDIANAPOLIS, IN -- (Marketwired) -- 08/05/14 -- YourEncore (www.yourencore.com), a company that helps life sciences, consumer products and food companies solve complex innovation, compliance and productivity challenges, has launched the Regulatory Center of Excellence, which will provide industry-accomplished experts to guide life sciences companies 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 percent 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 been providing regulatory expertise to life science companies since its founding in 2003. Working closely with Dr. Franson, 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 Regulatory Center of Excellence is comprised of experts carefully vetted by YourEncore in all areas of regulatory compliance, including:
- Regulatory strategy
- Regulatory chemistry manufacturing controls (CMC)
- Submission writing
- Advertising & promotion review
- Due diligence
The YourEncore Regulatory Center of Excellence 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 and Company.
"YourEncore's diverse professionals have deep expertise in a range of regulatory specialties, from strategy to operations, and with a broad scope of drug types, drug-device products and therapeutic areas," said Stephens. "We have a significant number of highly-qualified, seasoned regulatory experts ready to deploy; many of these experts are pharma industry alumni. We also are always looking for more regulatory experts to join the YourEncore team."
Indianapolis-based YourEncore helps companies in the life sciences, consumer products and food industries solve complex innovation, compliance and productivity challenges by deploying industry-accomplished experts. YourEncore experts, which include MDs, PhDs, executives and practitioners, have on average 25 years of experience and are behind many of the most successful products on the market. In addition to advisory services, the company also offers the resources to act on its recommendations. Founded in 2003, YourEncore today works with 12 of the 15 leading global pharmaceutical companies and 4 of the 6 top consumer care companies. For more information, visit www.yourencore.com and follow us on Facebook and LinkedIn.