The Medical Device Industry is undergoing a rapid change with an increase in the volume of regulations. Regulatory change management is an amalgamation of quality, compliance and risk management. …
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…
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…
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 …
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…
