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Results for: Hear From the Experts - Regulatory & Quality
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Leveraging Compliance for Sustainable Business Advantage
November 16, 2011
Article from Update Magazine, a publication of FDLI. “Leveraging Compliance for Sustainable Business Advantage” by Robert A. Rhoades, VP, Quality & Compliance Consulting -
CDRH's Proposed Changes to the Premarket Notification [510k]
May 27, 2011
On January 19, 2011, the FDA unveiled a plan to improve the 510(k) program, involving 25 actions the agency intends to implement during 2011, including new guidance and enhanced staf training. -
Podcast: Process Driven Compliance
March 31, 2011
Bob Rhoades, Practice Leader for Quality Systems with Consulting at Quintiles, explains the need for a process-driven approach to regulatory compliance. -
The Current Regulatory Landscape for Cardiac and Cardiovascular Safety Assessments - Part II
February 24, 2011
Last month, in Part I of this two-part series, we provided an overview of the history of formalized cardiac safety assessment, a brief discussion of -
Is a REMS Request From FDA More Likely for Drugs and Biologics Indicated for Pediatric Use?
February 23, 2011
The F ood and Drug Administration Amendments Act of 2007 (FDAAA) authorized the US Food and Drug Administration (FDA) to require that a Risk Evaluation -
The Current Regulatory Landscape for Cardiac & Cardiovascular Safety Assessments: Part I
February 22, 2011
The history of formalized cardiac safety assessment, and the dedicated study used to investigate a drug’s propensity to increase the length of the QT interval. -
The US Approval Pathway for Biosimilar Products
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). -
Demonstrating Bioequivalence for Locally Acting/Targeted Delivery Drugs
February 22, 2011
Bioequivalence studies play a crucial role in drug development as companies pursue line extensions, make manufacturing changes, develop generic drugs and seek US Food and Drug Administration (FDA) approval via the abbreviated drug approval pathway known as 505(b). -
Key Aspects of Pharmaceutical Due Diligence Intellectual Property Assessment—Part II
February 20, 2011
We provide overviews regarding the role of the regulatory professional, patent attorney (PA) and chemistry, manufacturing and controls (CMC) professional for the IP assessment. In addition, a case study is presented to tie together the concepts discussed in Parts I and II. -
Key Aspects of Pharmaceutical Due Diligence Intellectual Property Assessment—Part I
February 20, 2011
This article reviews regulatory legislation enacted to provide additional marketing exclusivity in addition to patent protection.
