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Medical Device Labeling Regulation Changes by FDA for COVID 19 period

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FDA is committed to providing timely guidance to support response efforts to this pandemic situation of COVID-19. In this regard FDA has implemented few guidance documents immediately without prio…

FDA/EU/MHRA/TGA Clin monitoring suggestions COVID

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There are several suggestions, recommendations from different health authorities for sponsors to handle clinical trial aspects during this very challenging time of COVID. Most of them recommended …

For Labeling Teams, What Does 10 Minutes Saving Per Day Means?

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That’s 40 hours time saved per year. The more per day time saving, obviously means more time saved in addition. Use this time that you’ll save for your strategic planning, process optimiza…

Most Common and Avoidable Mistakes While Adopting ISO 13485

In the process of implementation of QMS standard ISO 13485, many companies face common struggles; however their mistakes can be avoided when you look and analyze these things more closel…

Effectiveness and Flexibility of Adaptive Designs in Clinical Trials

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Drug development is becoming a complex process with each passing year. Expenses and time are not at per. Even success rates are dwindling over time and hence new drug development too loses the cha…