12.01.14
Quintiles has launched a new offering combining its pharmacovigilance, regulatory dossier/label maintenance, benefit-risk management, and analytic services, into an integrated solution aimed at better managing the licenses for marketed products.
The Marketed Product Maintenance (MPM) offering will provide data-driven insights on the benefit-risk profiles for a company’s products. It’s designed to enable customers to identify potential product risks, fulfill regulatory requirements, as well as make better decisions about their marketed products. According to the company, by using technology and subject matter expertise, the service connects post-approval requirements and license maintenance processes more effectively and efficiently.
“Within most biopharmaceutical companies, regulatory, safety maintenance and benefit-risk management functions could benefit from more interdependence,” said Paula Brown Stafford, president of Clinical Development at Quintiles. “Meanwhile, these companies are facing more complex safety and regulatory requirements, along with increasing budget constraints, making it increasingly difficult to achieve their regulatory obligations while improving the total cost of managing their established products. Integrating these functions through our innovative MPM solution will assist customers in maximizing the commercial value of their established products.”
The Marketed Product Maintenance (MPM) offering will provide data-driven insights on the benefit-risk profiles for a company’s products. It’s designed to enable customers to identify potential product risks, fulfill regulatory requirements, as well as make better decisions about their marketed products. According to the company, by using technology and subject matter expertise, the service connects post-approval requirements and license maintenance processes more effectively and efficiently.
“Within most biopharmaceutical companies, regulatory, safety maintenance and benefit-risk management functions could benefit from more interdependence,” said Paula Brown Stafford, president of Clinical Development at Quintiles. “Meanwhile, these companies are facing more complex safety and regulatory requirements, along with increasing budget constraints, making it increasingly difficult to achieve their regulatory obligations while improving the total cost of managing their established products. Integrating these functions through our innovative MPM solution will assist customers in maximizing the commercial value of their established products.”