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Top Trends of Enterprise Labeling in 2019

The market scenario of drug and device labeling is evolving rapidly and is evident with the FDA’s mandate PLR, PLLR drug labeling guidance, 21 CFR PART 801 general device labeling guidance. EU als…

Reg Information/Data for Devices, very important going forward!

Every day device manufacturers face challenges, especially if they have products in multiple countries. This can be from business needs or local demands or regulatory compliance that needs to be m…

Integration & Reconciliation IRT Guidelines

IRT’s main function lies in Supplies Distribution throughout the study and acts as a Medication Assigning Tool during Randomization/Enrollment. IRT is designed in such a way that it captures only …

Technology Towards an Efficient Monitoring of Clinical Trials

Clinical Study and Technology are two such genres that are progressing at a rapid rate. The implementation of age old practices does not suffice in any of the scenarios. Clinical trials are common…

Bulk/Non-Uniquely Number Kits in a Study

If the Kits in a study are not identified with a unique number (Kit Number), then the study is intended to make use of the advantages of Bulk/Non Uniquely Numbered Kits. This concept of Kits ca…

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