With EU MDR changing the plain field of med devices to a whole a new level, other countries are following similar path of increasing demands in product safety, traceability, performance areas.
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Labels of pharmaceutical products act as an “instruction manual” to the end-users hence need to be standardized. This standardization process is often met and overcome multiple obligations like co…
Content management is becoming a burden for the life science industry when it comes to labeling. The interdependency of all the phases has a negative impact on the revenue, the rate of sales, mark…
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…
