The Center for Drug Evaluation and Research (CDER) has recently launched two (2) quality management pilot programs for Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). The purpose of the pilot programs is to gain insight from the third-party assessments of the manufacturer’s quality management system (QMS) and enhance the future devel
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November 19, 2020 Compliance, Audit and Validation, Regulatory Affairs -
November 18, 2020 Compliance, Audit and ValidationIt is well known that COVID-19 has pushed many organizations to drive their auditors and the compliance teams adopt the right technology to perform remote audits. While remote audit techniques are similar to those of traditional audits, they leverage electronic means to obtain audit evidence for evaluations.
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September 30, 2020 Compliance, Audit and Validation, Regulatory AffairsTo support manufacturers during COVID-19, the EMA has updated guidance on the Regulatory expectations for the medicinal products. A new section of temporary flexibilities is added to inputs on good manufacturing practices (GMP), and good distribution practices (GDP). The new development is aimed at responding to the increased demand for medicinal products amid COVID-19.
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September 17, 2020 Compliance, Audit and Validation, Pharmaceutical, Regulatory AffairsPost-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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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.