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Start Small & Smart with Regulatory Automation

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Companies who did large implementations (like RIM, EDMS, Change Management, ERP, others) have all noticed their costs and timelines doubled than what is budgeted initially. These large systems …
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Clinical Trials through ‘Direct To Patient’ in COVID-19

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The COVID-19 pandemic has taken a toll on the entire world affecting various sectors including the pharmaceutical industry. Unlike the other industries, the pharmaceutical industry has not come to…
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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…
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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 …
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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…
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