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Results for: Get to market faster - Regulatory & Quality
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Quintiles Addresses Key Considerations for Successful Biosimilar Development
Press Release — September 29, 2011 – Regulatory and commercial considerations are the primary drivers for successful biosimilar development, according to a new report from Quintiles.
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Quintiles Names Rick Sax New Head of Integrated Clinical Services
Press Release — May 23, 2011 – Quintiles announced the appointment of Frederic “Rick” Sax as Senior Vice President and Global Head of its Integrated Clinical Services division.rograms.
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The US Approval Pathway for Biosimilar Products
Hear from the Experts — February 22, 2011
The Public Health Service Act allows biosimilars in the US. The law incorporates a specific subsection dealing with biosimilars entitled the Biologics Price Competition and Innovation Act of 2009 (BPCIA). -
Consulting – Breakthrough Thinking Built on Experience
Brochure — November 23, 2010
Consulting at Quintiles brings a critical element to engagements: fresh thinking built on a full lifecycle understanding of biopharma realities today. -
CMC, Preclinical and Clinical Considerations for Biosimilars and Follow-on Biologics
Hear from the Experts — July 7, 2010
This article summarizes some of the issues pertaining to biosimilars in Europe that are also likely to impact eventual FOB approval testing in the US. -
Regulations for Clinical Studies in Pediatric Patients in the European Union
White Paper — March 10, 2010
After the United States issued pediatric drug study requirements, the European Union (EU) passed a regulation that created major changes to clinical studies for pediatric -
Sub-Saharan Africa Phase II/III Fact Sheet
Brochure — July 29, 2009
Sub-Saharan Africa fact sheet about Phase II/III trials. The gateway to Africa: Access to expanded clinical resources and patient populations in South Africa and beyond. -
Adrian McKemey, Ph.D.
Hear from the Experts — March 25, 2009
Adrian leads the Product Development and Commercialization consulting practice at Quintiles Global Consulting. -
Jim Featherstone, Ph.D.
Hear from the Experts — March 25, 2009
Jim joined Quintiles Consulting from Wood Mackenzie, a leading business intelligence and strategy consulting services company based in the UK, where he was the Global Head of Consulting for the Pharmaceuticals and Biotechnology practice. -
Matthew Eberhart
Hear from the Experts — March 25, 2009
Matt is a proven business-building executive with a strong track record of implementing successful business development initiatives for consulting healthcare companies in both North America and Europe.