Post-Brexit, the biggest challenge for the pharmaceutical industry is its potential implication on Regulatory affairs. The derogation as a result of post-Brexit is expected to hit the pharmaceutical industry extremely hard, especially the Pharma companies operating in the UK.
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September 17, 2020 Compliance, Audit and Validation, Pharmaceutical, Regulatory Affairs -
August 25, 2020 Regulatory AffairsThe European Commission, along with the European Medicines Agency (EMA), released a notice to remind clinical trial sponsors to comply with the EU clinical trial rules following the Brexit transition period that is going to expire on 31 December, 2020.
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August 19, 2020 Food and Food Supplements, Consumer Healthcare, Cosmetics Regulatory ServicesAs we look at these challenging times for manufacturers across the life sciences industry, of course, not in terms of manufacturing products, but to market them across the globe compliantly, we understand there is a dire need for effective Regulatory solutions and services to ensure products compliant market entry.
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August 11, 2020 Medical Devices, Regulatory AffairsWith the continual rise of COVID-19 cases, the healthcare facilities are witnessing shortage of respirators. Assessing the critical shortage and enormous demand for respirators, the global Regulatory agencies are swiftly initiating significant efforts to develop practical methods for decontaminating used respirators effectively.
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November 29, 2019 Cosmetics Regulatory Services, Regulatory AffairsCosmetic products are one of the most widely used category of personal care products across the globe. Hence, they should be manufactured in a safe and effective manner. To ensure the same, Health Authorities across the world have established certain Good Manufacturing Practices (GMP).
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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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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.