Regulatory affairs

If we will search for RI anywhere we will be getting many results and definitions. The act of gathering and analysing publicly available regulatory information. This includes communicating the Implications of that information, and monitoring the cu

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One of the biggest mistakes I made early on as an entrepreneur was hiring cheap lawyers or not using an expensive lawyer nearly enough, thinking I was saving money for my business. But over the years, the school of hard knocks taught me just how expensive cheap legal help can [...]

Regulatory Affairs is a very important part of regulated industries that manufacture products intended for human use. One such and also the most important is the pharmaceutical industry. Any product cannot enter the market unless and until it is authorized by the concerned

Everyone agrees that advances in medicine have helped increase the average human lifespan by decades more than it used to be. Thank goodness for that! Few people realize exactly what it takes to “advance medicine” in modern times, however. When talking about selling a new pharmaceutical drug, aka bringing a new pharmaceutical to market, the…

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Produce regulatory publishing submissions (e.g., INDs, NDAs, NDSs, MAAs, annual reports, routine submissions, Clinical Study Reports) in accordance with US and global requirements, using electronic publishing tools, and an EDMS system. Perform independent publishing QC on published output, complete appropriate checklists and/or provide assessments for the activities around the quality of report-level publishing and submission readiness of source documents for submission-level publishing.