The pharmaceutical supply chains are highly complex, with multiple stakeholders like manufacturers, suppliers, technology providers, packaging partners, and retailers obliged to maintain the Regulatory standards for quality, safety, and procedural accuracy throughout the product lifecycle.
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February 28, 2020 Regulatory Labeling, Regulatory Affairs -
February 28, 2020 Regulatory Artwork Services, Medical Devices, Regulatory Labeling, Regulatory AffairsTo ensure high standards of quality and safety for medical devices being produced or supplied, the European Union (EU) has released a new Medical Device Regulation (MDR) in May 2017. As the three-year transition period for medical device manufacturers will come to an end from May 26th, 2020, organizations must relook at implementing compliant processes and procedures accordingly.
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February 27, 2020 Regulatory LabelingIt is evident that the labeling requirements in the European Union (EU) are quite dissimilar, given various region-specific regulations across the 27 member states. Besides this, the emerging European Regulatory landscape demands life sciences manufacturers to be more cautious in implementing and showcasing the safety information.
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December 31, 2019 Food and Food Supplements, Regulatory Labeling, Regulatory AffairsIn 2016, the United States Food and Drug Administration (FDA) released final rules for the revised Nutrition Fact Labels, a part of which will be effective from the year 2020. It was initiated by the USFDA to help consumers make informed food choices and promote a healthy diet and lifestyle.
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November 26, 2019 Pharmaceutical, Regulatory Labeling, Regulatory AffairsDYK? Australian Regulatory framework for therapeutic goods has been evolving with regards to labeling requirements. It is clearly evident with the Therapeutic Good Administration’s (TGA’s) recent announcements and proposed labeling requirements. Recently, it has announced certain guidelines for using the ‘TGA assessed claim’ on medicine labels.
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October 31, 2019 Pharmaceutical, Regulatory Labeling, Regulatory AffairsMedicine labels act as a first-hand guide for the users and help to use the products qualitatively. Therefore, it is highly important to that the information available on the labels is consistent, easy-to-read and error-free, and on par with the global standards.
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October 18, 2019 Regulatory Labeling, Regulatory AffairsIn today’s rapidly changing global Regulatory scenario, companies must keep on par with evolving global label changes while creating, tracking, and managing different aspects of labeling((Please rephrase)).
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September 18, 2019 Regulatory Labeling, Regulatory AffairsIn Life Sciences arena, global health authorities always guide and mandate the manufacturers to demonstrate the safety and efficacy of a product through compliant labeling procedures. It is because the labels act as key channels of communication between the product and the end user.
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July 8, 2019 Regulatory Labeling, Regulatory AffairsLabeling, perhaps the most looked-after section of any product; either a medicinal product, medical device or a cosmetics product. As it furnishes the first-hand information about the product to the outside world, Life Sciences manufacturers across the globe are obliged to manage this piece of information as accurately as possible to win the end-user’s trust.
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July 4, 2019 Cosmetics Regulatory Services, Regulatory LabelingIn the European Union (EU), a cosmetic marketing claim is regulated under EU Regulation (EC No. 655/2013). The Annex III – ‘free from’ claims were added on the July 3, 2017 to the list of regulations to be effective/mandated from July 1, 2019. At the same time the Annex IV ‘hypoallergenic’ claim was introduced.