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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January 31, 2020 Cosmetics Regulatory ServicesTo strengthen the cosmetic product regulations in South Korea, the Ministry of Food and Drug Safety (MFDS) introduced six draft amendments in 2019. The amendments focus on various Regulatory aspects of cosmetic products such as manufacturing, scrutiny, labeling etc.
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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 30, 2019 Regulatory Intelligence, Regulatory AffairsLife 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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August 30, 2019 Pharmaceutical, Regulatory AffairsAre you a manufacturer of Prescription and Over the Counter (OTC) drugs? Then it is obvious that you are aware of the US Consumer Product Safety Commission (CPSC) regulations under which certain consumer products, including many prescription and OTC drugs are subject to special packaging standards, including Child-Resistant Packaging (CRP) Statements in drug labels.
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August 7, 2019 Cosmetics Regulatory Services, Regulatory AffairsTo place a cosmetic product successfully in a market, manufacturers are required to decode and comply with the cosmetic regulations of the target country. While some countries follow the global cosmetic regulations, others have their own set of regulations established to monitor the products.
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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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June 6, 2019 Food and Food Supplements, Regulatory LabelingMore than ever, consumers these days are concerned about their personal health and well-being and are keen on looking for informative product labels for correct usage. This has given rise to several trends in the food labeling industry.