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 19, 2022 Regulatory Contract Staffing, Regulatory Affairs
- 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.
- December 6, 2022 Medical Devices, Regulatory Affairs
The Pharmaceuticals and Medical Devices Agency (PMDA) releases Medical Device Safety Communications (MDSCs) to convey important safety information to patients and healthcare professionals. PMDA releases different types of safety communications, such as:
- November 30, 2022 Medical Devices, Regulatory Affairs
In a global marketplace with more than 7,100 spoken languages, manufacturers need to consider the local language and culture when developing medical device product labels. How does one make it possible to reach out to a diverse group of people?
- November 29, 2022 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
Marketing Authorization Holders (MAHs) with medicinal products authorized for marketing in the European Economic Area (EEA) have a legal responsibility of establishing a PV system for accomplishing PV obligations for their products. To this end, the MAHs in the European Union (EU) must appoint an appropriately qualified person for PV (QPPV). The role and responsibilities of the QPPV include, but are not limited to: