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By Kristin Brooks
Published February 26, 2014
Schmoetzer brings extensive industry experience Read More »
Regulatory Affairs For Components
By Debbie Thomas and Steve LoCastro, West Pharmaceutical Services, Inc.
Published November 9, 2012
Building stronger regulatory support for pharma Read More »
CMC and Regulatory Affairs
By Edward A. Narke, DS InPharmatics
Published September 6, 2012
See the forest and the trees Read More »
By Beverly Lewis
Published August 22, 2005
How to get the most from regulator providers Read More »
By Sandy Hatten
Published August 22, 2005
In a contract manufacturing relationship, who is ultimately responsible for the regulatory component? Read More »
Clinical Trial Supplies 101: An Outsourcing Primer for Virtual Pharma and Biopharma Companies, Part1
By Joseph Iacobucci and Damian Gant , Clinical Supplies and Xcelience
Published September 8, 2014
Getting packaged investigational materials dispensed to the patients taking part in clinical trials, on time and correctly, requires orchestrating myriad activities. Outsourcing makes the process even more complex. This series of articles presents tips on how to do it right. Read More »
Improving the Functional Characterization of Biosimilars
By Delana Butz, Ph.D., Manuela Grassi, Ph.D, Onesmo Mpanju, Ph.D., Duu-Gong Wu, Ph.D., Peter Wunderli, Ph.D. , PPD
Published June 3, 2014
New bioassay methods may help reduce the variability of analytical methods required to demonstrate comparability Read More »
Ensuring Drug Quality in a Global Economy
By Helena Champion , Principal Consultant, Drug Quality Assurance LLC
Published May 1, 2014
Offshore CMO’s have proven a weak link in pharma’s supply chain. Will recent quality problems in India and China increase oversight? Read More »
By Laura Cano, Key Account Manager
By S. Harachand
Published September 7, 2011
Sudden spurt in pharmacovigilance activity Read More »


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