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Most Common and Avoidable Mistakes While Adopting ISO 13485

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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…
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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…
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Regulatory Data and Info Management for Med Device Success

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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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Labeling of Pharmaceutical Products: Challenges and Standardization

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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…
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Linked Labeling: Maximizing Content Management Complexity?

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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…
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