Isn’t it interesting to see Artificial Intelligence (AI) sculpting out to have a thriving position in the Regulatory landscape? One of the most important reasons for this advancement is the ability of AI and Machine Learning (ML) applications to tackle everyday procedural challenges and logical issues that compliance officers put up with.
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February 5, 2021 Regulatory Affairs, Regulatory Intelligence
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February 5, 2021 Regulatory Affairs, Regulatory Intelligence
Sustaining the ever-evolving global Regulatory space of the life sciences industry is strenuous. Therefore, it is necessary for manufacturers to keep abreast with the latest Regulatory information to ensure compliance across all the business functions, such as clinical development, release, and marketing scrutiny of medicines.
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October 6, 2020 Compliance, Audit and Validation, Pharmaceutical, Regulatory Intelligence, Regulatory Affairs
As we all aware, COVID-19 pandemic resulted in the suspension of regular on-site inspections and as the world is slowly coming out of COVID-19 restrictions, Health Agencies are eying on resuming the on-site inspections.
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September 30, 2019 Regulatory Intelligence, Regulatory Affairs
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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January 31, 2019 Medical Devices, Regulatory Affairs, Regulatory Intelligence
National Medical Products Administration (NMPA), formerly known as China Food and Drug Administration (CFDA), is all set to impose stricter regulations on auditing and reinforcement of clinical trials. To ensure best practices for in vitro diagnostic device (IVD), the agency released “Draft IVD Clinical Trial Guideline for Feedback” on November 22, 2018.
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December 27, 2018 Regulatory Artwork Services, Food and Food Supplements, Compliance, Audit and Validation, Consumer Healthcare, Cosmetics Regulatory Services, Medical Devices, Pharmaceutical, Registration Strategy, Regulatory Intelligence, Regulatory Labeling, Regulatory Software & Services, Regulatory Affairs, Market Access, Regulatory Consulting, Publishing & Submissions, Regulatory Medical Writing, Health Authority Updates
The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.
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December 24, 2018 Regulatory Intelligence, Regulatory Affairs
Artificial Intelligence (AI) is by far the most talked about technological advancement of this decade. Although the idea of AI has been around for years, the processers and computational speed of the previous era were not up to the mark, thus couldn’t support the analysis of huge data as required.
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November 22, 2018 Regulatory Intelligence, Regulatory Affairs
As a big face lift, Health Authorities of China and South Africa have recently revealed their identifications. The China Food and Drug Administration (CFDA), has recently announced the change related to the agency’s official English name, the National Medical Product Administration (NMPA).
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June 7, 2017 Pharmaceutical, Regulatory Intelligence
When it comes to measuring the success of a new medicine, the amount of time taken to complete the entire approval process becomes a crucial factor. With the growing need to speed up the market launch and address the unmet needs of patients, major global health authorities have in turn accelerated the drug approval processes.
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March 2, 2017 Regulatory Intelligence, Regulatory Consulting
Wading through uncharted waters is always risky and mount numerous pressures on organizations. It not only affects organization’s financial status quo but also impose threat to brand image. If it is the same in the life sciences sector, the situation may lead to incompliance and untimely drug approvals thus posing a threat to patient safety.