As you may know, CE marking is required to place any In Vitro Diagnostics devices (IVDs) in the European Union (EU). CE marking indicates that the given product complies with the European Union In Vitro Diagnostics Device Regulations (EU IVDR) 2017/746. We are all aware that the process is more complex than it seems.
- December 23, 2022 Medical Devices, Regulatory Affairs
- December 23, 2022 Medical Devices, Regulatory Affairs, Regulatory Labeling
Medical device labeling is a critical part of any device. It provides information to the consumer in textual or graphic forms on the packaging. It intends to increase the safety and usage instructions for consumers.
- December 22, 2022 Pharmaceuticals
On May 11, 2022, Japan’s Diet passed the ground-breaking “Act on Promotion of Economic Security by Integrated Implementation of Economic Measures” apropos to the government’s policy push reform considering the global unrest and increasing geopolitical risks.
In talks since 2021, the Act was finally approved on May 11, 2022. It is expected to enter into force on or before February 18, 2023.
- December 19, 2022 Regulatory Contract Staffing, Regulatory Affairs
Regulatory Affairs Staff augmentation is a trusted and proven staffing model that infuses the right talent at the right place at the right time into the life science organization’s flexible workforce plan.
- December 15, 2022 Medical Devices, Regulatory Affairs
Labeling is defined as the “display of written, printed, or graphic matter upon the immediate container of any article.” Any medication that is intended to be distributed must be labeled as per the Parts of Title 21 of the Code of Federal Regulations (CFR).
- December 9, 2022 Cosmetics Regulatory Services, Regulatory Affairs
Preservatives are used in cosmetic products to ensure their safety during their lifetime. As many cosmetics contain water, once exposed to the environment, they become prone to the growth of microorganisms. Furthermore, every time a consumer interacts with the product, it gets introduced to a new population of microorganisms directly from the air or skin.
- December 9, 2022 Medical Devices, Regulatory Affairs
An organized system of protocols and practices known as a medical device quality management system (QMS) addresses all facets of design, production, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more.
- December 9, 2022 Pharmaceuticals, Regulatory Medical Writing
A comprehensive compilation of clinical and nonclinical data on the investigational product (drug, supplement, device, or other product) provides a brief description of the drug substance and the formulation, including the structural formula (if known).
- December 8, 2022 Medical and Scientific Communication, Pharmaceuticals, Regulatory Affairs
Marketing promotions and advertisements in Pharmaceuticals are information of nexus where research concepts are transformed into realistic therapeutic tools, and information is made useful for different sectors in the Health care system. Every year pharmaceutical companies spend a large part of their revenues on promotions and advertising for the successful launch of pharmaceutical products.
- December 6, 2022 Medical Devices, Regulatory Affairs
The importance of post-market surveillance (PMS) has never been out of the buzz. Regulatory Authorities worldwide have established some stringent rules and regulations to efficiently monitor medical devices even after placing them on the market. Similarly, the European Union (EU) has emphasized PMS in its new regulations.