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- April 20, 2023 Publishing & Submissions, Regulatory Software & Services
- April 20, 2023 Pharmaceuticals, Regulatory Affairs, Publishing & Submissions
A Certificate of Suitability (CEP) certifies the Active Pharmaceutical Ingredients (APIs) manufacturing companies’ edge in demonstrating quality, safety, and efficacy to the Regulatory authorities. A CEP is a publicly available certificate issued by the European Directorate for the Quality of Medicines (EDQM).
- April 20, 2023 Biologicals, Pharmaceuticals, Regulatory Medical Writing
After the United States Food and Drug Administration (US FDA)’s guidance document, titled ‘Integrated Summaries of Safety and Effectiveness (ISS/ISE): Location Within the Common Technical Document,’ was released in April 2009, the significance of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) increased.
- April 19, 2023 Medical Devices
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
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.