Quintiles Launches Marketed Product Maintenance Offering to Better Manage Established Products
December 01 2014 - 8:11AM
Business Wire
Quintiles today 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
biopharmaceutical 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, biopharmaceutical companies can
generate greater return on investment from their portfolio of
established products by redeploying resources on prioritized,
growth-oriented products.
“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.”
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:
- Ninety-nine percent on-time compliance
for approximately 1.5 million clinical, post-marketing, and device
safety reports processed globally since 2009;
- One hundred percent of approximately
1,500 electronic common technical documents (eCTDs) submitted to
the EU, U.S. and Canada passed technical validation.
For more information about the MPM Solution, visit
www.quintiles.com/MPM.
About Quintiles
Quintiles (NYSE:Q), a Fortune 500 company, is the world’s
largest provider of biopharmaceutical development and commercial
outsourcing services. With a network of more than 32,000 employees
conducting business in more than 100 countries, we helped develop
or commercialize all of 2013’s top-100 best-selling drugs on the
market. Quintiles applies the breadth and depth of our service
offerings along with extensive therapeutic, scientific and
analytics expertise to help our customers navigate an increasingly
complex healthcare environment as they seek to improve efficiency
and effectiveness in the delivery of better healthcare
outcomes. To learn more about Quintiles, please visit
www.quintiles.com.
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QuintilesMari Mansfield, Media Relations
(mari.mansfield@quintiles.com)+ 1-919-998-2639, +1-919-259-3298
(mobile)orKarl Deonanan, Investor Relations
(InvestorRelations@quintiles.com)+1-919-998-2789
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