Digital therapeutics, also known as software-based therapies, have gained significant attention as an alternative treatment option for various chronic diseases.
- April 19, 2023 Medical Devices
- April 19, 2023 Medical Devices
The combination product market continues to grow as pharmaceutical, medtech, biotech, and life science companies keep innovating. Combination devices and drug products can provide more targeted treatment, enable better drug delivery, and improve the efficacy of both medical devices and drugs. The definition of combination products and their governing regulations varies between countries.
- April 19, 2023 Medical Devices
Cybersecurity is a critical component of the designing, developing, and deploying medical devices. As cyberattacks can manipulate or destroy personal and sensitive patient data, Regulatory Agencies worldwide are now strengthening the Regulatory requirements to ensure medical device cybersecurity.
- April 12, 2023 Medical Devices
Label maintenance and updating is the process of ensuring that the data on the label stays up-to-date and accurate throughout the life cycle of the device. This could entail updating information to meet new laws or standards, amending the existing labels to reflect changes in the product or its intended use, or fixing typographical errors.
- April 12, 2023 Cosmetics Regulatory Services, Regulatory Affairs, Regulatory Labeling
Japan, being one of the most affluent nations in Asia, has witnessed tremendous growth in its cosmetic market. It is the third-largest cosmetic market in the world. Japanese consumers are sophisticated and well-informed about products and formulations with respect to cosmetics. Natural and organic ingredients are in huge demand in the market, which drives manufacturers to launch products with natural/ clean product labels…
- April 12, 2023 Medical Devices
The Brazilian Health Regulatory Agency, ANVISA, issued Resolution RDC 751, which recently specified the standards and guidelines for the notification, registration, post-approval modifications, and revalidation of medical devices in Brazil. ANVISA’s Resolution of the Board of Directors (RBD) No. 751/2022 was recently published and has been effective from March 01, 2023.
- April 12, 2023 Medical Devices
In Indonesia, the Good Method for the Distribution of Medical Devices, locally known as the Cara Distribusi Alat Kesahatan yang Baik (CDAKB), is a set of guidelines used in a series of distribution and quality control activities aimed at ensuring that the distributed medical device products meet the requirements for their intended use.
- April 12, 2023 Regulatory Contract Staffing, Regulatory Affairs
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 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.