Staff augmentation is a common strategy deployed by companies to expand their workforce, especially in highly regulated industries such as Pharmaceuticals and Healthcare. However, there are many misconceptions surrounding Regulatory staff augmentation, which can lead to negative consequences for both the company and its employees.
- April 12, 2023 Regulatory Contract Staffing, Regulatory Affairs
- April 10, 2023 Pharmaceuticals, Publishing & Submissions
Effective January 31, 2022, the new European Union (EU) pharmaceutical regulation for Clinical Trials Regulation (CTR) has become mandatory, repealing the Clinical Trials Directive 2001/20/EC. The regulation harmonizes protocols for evaluating and supervising clinical trials across the EU.
- April 7, 2023 Publishing & Submissions, Regulatory Software & Services
Hello, esteemed Regulatory professionals! As a member of the life science industry, you are likely to be familiar with the electronic Common Technical Document (eCTD) submission format that is revolutionizing the Life Sciences Regulatory industry. Its standardized structure is a true game-changer. With this blog, we aim to provide valuable insights into the best practices for eCTD submissions.
- April 6, 2023 Medical Devices, Regulatory Affairs
A list of medical devices that fall within the Class A, Class B, Class C, and Class D categories were included in the 2017 New Medical Device Regulations (MDR). Based on the level of risk they pose, Class A and B devices are categorized as low-risk and moderate-risk devices, respectively, whereas Class C and D devices are classified as high-risk and extremely high-risk devices, respectively.
- April 5, 2023 Medical Devices, Regulatory Affairs
The driving factors behind the medical device industry are still evolving, as the Gulf Cooperation Council (GCC)’s healthcare expenditure is rising dramatically. To maintain this trajectory, The GCC has developed a portal called Taawon to facilitate the registration and approval of drugs and medical devices in GCC countries.
- April 5, 2023 Medical Devices, Regulatory Affairs
Medical device manufacturers must complete the Gulf Cooperation Council (GCC) medical device registration process to sell their products in Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates (UAE). The registration procedure ensures that the medical devices sold in these countries adhere to the essential quality and safety requirements as well as the relevant regulations.
- March 27, 2023 Food and Food Supplements, Regulatory Affairs
Claims are a vital aspect of marketing food and dietary supplements, as they help consumers understand accurate details of the product. In the United States of America (USA), food and dietary supplement products are regulated by the United States Food and Drug Administration (US FDA).
- March 24, 2023 Medical Devices, Regulatory Affairs
What is an RTA?
In the context of medical device Regulatory Affairs, a Refusal to Accept (RTA) is a request from the US FDA for additional information or clarification on information submitted in a 510(k) application.
- March 24, 2023 Medical Devices
The development of In-Vitro Diagnostic (IVD) devices is a classic example in the healthcare sector, where modern technology has enabled healthcare professionals to improve treatment regimes for serious life-threatening health conditions. While Regulatory agencies worldwide are working towards harmonized regulations to market IVDs, China’s NMPA has led to stringent guidelines for the regulation of IVDs in China market.
- March 24, 2023 Medical Devices, Regulatory Affairs, Regulatory Medical Writing
The analytical performance is described in European Union In Vitro Diagnostic Regulations (EU IVDR) 2017/746 as “the ability of the device to correctly detect or measure a particular analyte.” The analytical performance of any IVD/s is demonstrated based on the analytical performance studies, which are then documented as Analytical Performance Report (APR).