Industry-Accomplished Experts Available to Help Pharma Companies Meet All GXP Quality Requirements
INDIANAPOLIS, IN--(Marketwired - Sep 10, 2014) - 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 Quality Center of Excellence, which provides industry-accomplished experts to guide life sciences companies through complex regulatory compliance and product integrity requirements throughout the product lifecycle in both large and small pharma.
Concerns about drug quality prompted the Food and Drug Administration (FDA) to create a new oversight unit in 2014. The Office of Pharmaceutical Quality was established to give more scrutiny to brand name, generic and over-the-counter drugs, especially those from overseas."FDA data shows that pharmaceutical recalls are on the rise," said Tim Franson, M.D., YourEncore's Chief Medical Officer. "In addition, the number of foreign-made drugs entering the United States market has grown substantially, increasing the need for strong quality programs. YourEncore's experts have decades of experience supporting quality projects and programs in clinical, manufacturing, pharmacovigilance and laboratory practices, and are available to rapidly deploy."
YourEncore has been providing quality expertise to life science companies since its founding in 2003, helping companies be in compliance with all GXP requirements, including Good Pharmacovigilance Practices (GPvP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP). 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 Quality Center of Excellence is composed of experts carefully vetted by YourEncore in all areas of pharmaceutical quality assurance, including:
- Quality Systems
- Audits and assessments
- Due diligence
- Risk management
- Inspection and remediation advisory services
The YourEncore Quality Center of Excellence is led by Jo Ann Wells, who has nearly 25 years of experience in the pharmaceutical industry, including over 20 years in quality assurance for companies such as Pfizer and Aastrom Biosciences.
"YourEncore's professionals have deep expertise in a range of quality specialties, including site, document and process audits, regulatory inspection mediation, and assessments of post-marketing patient support programs. Our experts have worked with a broad scope of drug types, including small and large molecule, generics, OTC and medical devices," said Wells. "We have a significant number of highly-qualified, seasoned quality experts ready to deploy."
Indianapolis-based YourEncore, an Inc. 5000 company, 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 four of the six top consumer care companies. For more information, visitwww.yourencore.com and follow us on Facebook and LinkedIn.