Life sciences, as an industry, is dynamic in nature due to constant Regulatory enforcement from global health authorities. In such a scenario, as there would be continuous modifications to the safety information that has to be conveyed through drug labels, the label lifecycle management is treated as a mission-critical system.
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September 30, 2019 Regulatory Intelligence, Regulatory Affairs -
June 21, 2019 Food and Food SupplementsPrevention of food safety issues has been a primary focus for the United States Food and Drug Administration (US FDA) over the past decade. To monitor and enhance food safety, FDA has introduced Food Safety Modernization Act (FSMA) in 2011, which emphasizes on all the aspects of food production, and supply chain; from farm to fork.
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When it comes to personal care and cosmetic products, cosmetic manufacturers must adhere to the safety and efficacy Regulations to make sure their products are safe for consumption.
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March 7, 2019 Medical DevicesDid you know? The US Food and Drug Administration (FDA) has set yet another high record by approving 106 novel devices in 2018, making it the most successful year for medical devices. With this accomplishment, FDA has surpassed its 40-year old record set in 2017 of approving 99 novel devices, showing a continuous growth for the past 8 years.
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December 10, 2018 PharmaceuticalThe advent of internet has fundamentally changed the course of action of almost every industry. Even though internet has been around for a while, it wasn’t until the emergence of Industry 4.0 that the digital transformation started helping the industries to evolve.
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December 6, 2018 Compliance, Audit and ValidationLife sciences industries are stepping ahead with new initiatives every day to align with the growing Regulatory restrictions put forth by the health authorities. But as the supervisory expectations of agencies are evolving at an increased pace, at times, organizations are finding it challenging to align with all of them on time.
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October 22, 2018 Regulatory AffairsIn the current competitive landscape of Life Sciences, it is required to reduce the time-to-market for a quick product launch to take advantage of early success. For the same, manufacturers should ensure that all Regulatory aspects are adhered within the submission deadlines for successful approvals.
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August 30, 2018 Cosmetics Regulatory ServicesBrazil’s cosmetic market is flourishing, showing no signs of slowdown even in the economic fluctuations. In Brazil, cosmetics in various segments such as organic, skincare, haircare, etc. are gaining popularity among users, and their market extent is increasing day by day.
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June 1, 2018 Medical DevicesOn April 5, 2017, the European Commission has approved the new Medical Device Regulations (MDR) - 2017/745-MDR and 2017/746-IVDR, which have come to effect in force (EIF) from May 25, 2017.