MHRA guide for labeling and packaging
MHRA Guide for Labeling and Packaging
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Medical Dictionary for Regulatory Activities (MeDRA) by ICH
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The factsheet provides information on how organisations can access the Medical Dictionary for Regulatory Activities (MedDRA), as well as...
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Global Specialty Enzymes Industry 2015
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NEW YORK, June 4, 2015 /PRNewswire/ — This report analyzes the worldwide markets for Specialty Enzymes in US$ Million...
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US FDA issues draft norms on waiver of in-vivo BA & BE studies for subsequent analysis; pharma cos to save time, cost – Courtesy(Pharmabiz.com)
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The US FDA has issued draft guidelines on waiver of in-vivo bioavailability (BA) and bioequivalence(BE) studies for immediate release...
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Regulatory Dark Horse? EU Directive on Cross-Border Patients’ Rights – Courtesy (pharmaexec.com)
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The European Union’s directive on patients’ rights in cross-border healthcare was seen as a bit of a damp squib...
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Root Cause Analysis (RCA)
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Identifying the root cause for market complaints, out of specifications (OOS), deviations can be challenging, but a number of...
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Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients
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Comparision of NDA procedures & Regulatory structures in Turkey and Canada
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About Authors:Abhisek Shukla*, Dr. Valluru RaviPharmaceutical Regulatory Affairs group, Dept. of Pharmaceutics,JSS College of Pharmacy, JSS University,Sri Shivarathreeshwara Nagar,...
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Janssen’s Fruitful Continuous Manufacturing Collaboration
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Janssen Supply Chain, part of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), has a long-standing collaborative partnership...
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