The solution will help biopharma companies better manage all activities required to maintain the licenses for their portfolio of marketed products
Quintiles announced a new offering that combines its industry-leading pharmacovigilance, regulatory dossier/ label maintenance, benefit-risk management and analytic expertise into one integrated solution. This solution will help biopharmaceutical companies better manage all activities required to maintain the licenses for their portfolio of marketed products.
Underpinned by a fully-integrated technology platform, the new offering, called Marketed Product Maintenance (MPM), will provide biopharma companies with greater data-driven insights on the benefit-risk profiles of their products. These enhanced insights will enable customers to identify potential product risks, fulfill increasingly complicated regulatory requirements and help them make better decisions about their marketed products. By using technology and subject matter expertise to connect the post-approval requirements and license maintenance processes more effectively and efficiently, biopharma companies can generate greater return on investment from their portfolio of established products by redeploying resources on prioritised, growth-oriented products.
Paula Brown Stafford, President of Clinical Development, Quintiles said, “Within most biopharma companies, regulatory, safety maintenance and benefit-risk management functions could benefit from more interdependence. 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 maximising the commercial value of their established products.”
These services will be delivered globally as an integrated and efficient turnkey solution, leveraging Quintiles’ extensive safety, regulatory, benefit-risk management research experience, as evidenced by:
- 99 per cent on-time compliance for approximately 1.5 million clinical, post-marketing, and device safety reports processed globally since 2009;
- 100 per cent of approximately 1,500 electronic common technical documents (eCTDs) submitted to the EU, US and Canada passed technical validation.
EP News Bureau – Mumbai