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CONTENTS


In this Issue 10 | INSIDER INSIGHT


Coming Clean on Quality in the Chemical Manufacturing Lab


Ed Price, President PCI Synthesis


12 | CMOS Biopharma Vendors Offering Services Bundled With Products: Vendors see opportunities as outsourcing demand rises; may compete with CMOs


Eric S. Langer, Managing Partner BioPlan Associates, Inc.


26 | RESEARCH


What Are the Latest Guidelines for Excipients? Guy Tiene, Director of Strategic Content That's Nice LLC/Nice Insight


32 | INSIDER INSIGHT


Current Trends in Global Distribution and Supply Chain Dave Dreifke, Manager, Clinical Supply Chain & Logistics Xcelience, a division of Capsugel Dosage Form Solutions


36 | SUPPLY CHAIN


Brazil: Improving Your External Relationship Management for More Effective Temperature- Controlled Logistics


Luiz Alberto Barberini, CQE, CPIM , MBA External Relationship Operations Manager LatAm Bayer SA, Brazil


40 | HORIZON LINES


Horizon Lines: A Yearly Review of NDAs - 2015 Harshada Sant, MS, Amitkumar Lad, PhD and Hemant N. Joshi, PhD, MBA Tara Innovations LLC


The right combination of Process Chemistry & Analytical Solutions for your cGMP API.


Pharma ChemOutsourcing 2016 SEPT. 19-21* BOOTH 33 Please visit us at


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CREATING THE PATH FOR SUCCESS


API TECHNOLOGY DEVELOPMENT 905 403 0477 alphoraresearch.com


REGULAR FEATURES 2 EDITOR'S MESSAGE


7 EDITORIAL ADVISORY BOARD 8 CN PERSPECTIVES 9 SOCIAL MEDIA CONNECTIONS 30 CHEMOUTSOURCING 2016 EVENT PREVIEW 43 INDUSTRY NEWS 48 ADVERTISER’S INDEX


Pharmaceutical Outsourcing | 6 | July/August 2016


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