09.12.14
YourEncore has launched the Quality Center of Excellence, which provides industry experts to help guide life sciences companies through complex regulatory compliance and product integrity requirements throughout the product lifecycle.
In 2014 the FDA established a new oversight unit to deal with drug quality concerns, giving more scrutiny to brand name, generic and OTC drugs, especially those from overseas. Working closely with Dr. Franson, the CoE will further expand its available expertise with all GXP requirements, including Good Pharmacovigilance Practices (GPvP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP), providng clients with faster access to a database of experts for targeted solutions.
The CoE covers all areas of pharmaceutical quality assurance, including: quality systems audits and assessments, due diligence risk management, inspection, and remediation advisory services training.
“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.”
In 2014 the FDA established a new oversight unit to deal with drug quality concerns, giving more scrutiny to brand name, generic and OTC drugs, especially those from overseas. Working closely with Dr. Franson, the CoE will further expand its available expertise with all GXP requirements, including Good Pharmacovigilance Practices (GPvP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP), providng clients with faster access to a database of experts for targeted solutions.
The CoE covers all areas of pharmaceutical quality assurance, including: quality systems audits and assessments, due diligence risk management, inspection, and remediation advisory services training.
“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.”