In the pharmaceutical industry, patient safety is a top priority, and advancements in technology are being leveraged to improve the accessibility and comprehensiveness of product information. One such technological innovation that holds great promise for enhancing patient safety is the implementation of QR codes in pharmaceutical labeling.
- February 22, 2024 Pharmaceuticals, Regulatory Labeling
- February 22, 2024 Pharmaceuticals, Regulatory Labeling
The pharmaceutical industry operates within a highly regulated environment, where compliance with global Regulatory labeling requirements is paramount. As we look to the future, several key trends and developments are poised to shape the Regulatory labeling landscape, presenting both opportunities and challenges for pharmaceutical companies.
- February 22, 2024 Food and Food Supplements
Introduction
The European Union (EU) has implemented groundbreaking regulations for wine labeling, which have been effective from December 08, 2023. The regulations are applicable to wines manufactured from the 2024 harvest onward. These regulations aim to enhance consumer information by requiring detailed labels, including ingredient lists and nutritional values.
- February 22, 2024 Pharmaceuticals, Regulatory Affairs
In the dynamic universe where pharmaceuticals intersect, combination drug products have emerged as pioneers of innovation. This promising fusion, however, brings forth a symphony of challenges, notably in the realm of impurities. The Regulatory path for managing impurities in combination drug products is a nuanced journey, demanding a profound grasp of both pharmaceutical science and Regulatory intricacies.
- February 22, 2024 Pharmaceuticals, Regulatory Affairs
The pharmaceutical industry is at the forefront of technological advancements, research breakthroughs, and innovative drug development. In this rapidly evolving landscape, maintaining pharmaceutical Regulatory compliance is paramount to ensure patient safety, Regulatory adherence, and the integrity of the industry. Pharmaceutical Regulatory compliance is complex but surmountable.
- February 22, 2024 Pharmaceuticals, Regulatory Medical Writing
In the dynamic realm where medical breakthroughs intersect with stringent Regulatory frameworks, the journey of clinical trials unfolds. At a critical juncture where innovation converges with compliance, clinical trials are the conduits through which transformative therapies reach the hands of those who need them. At the epicenter of this intricate dance is the evolving role of Regulatory vendors.
- February 22, 2024 Pharmaceuticals, Regulatory Medical Writing
In the dynamic landscape of clinical trials, advanced clinical trial monitoring techniques are reshaping the way we conduct and perceive these critical studies. This blog is your compass through this transformative journey, unveiling the innovations and strategies driving the evolution of clinical trial monitoring.
- February 19, 2024 Food and Food Supplements
In a significant development, the Board of Food Standards Australia New Zealand (FSANZ) issued a crucial notification on December 07, 2023, titled “Food Standards Variation on Added Sugars for Claims”. This notification, executed under Section 92 of the Food Standards Australia New Zealand Act, 1991, brings forth noteworthy changes to the Australia New Zealand Food Standards Code.
- February 16, 2024 Medical Devices
21 Code of Federal Regulations (CFR) Part 820, also known as the Quality System Regulation (QSR), is part of the United States (US) CFR that establishes the criteria under which medical devices are manufactured. It covers various aspects of the manufacturing process, including design, production, labeling, storage, installation, and servicing of medical devices.
- February 16, 2024 Medical Devices
Post-market Surveillance (PMS), in the context of Quality Management Systems (QMS), refers to the systematic approach to collecting, recording, and analyzing data on the quality, performance, and safety of a medical device throughout its entire lifecycle, actively and continuously. This process is an integral part of a manufacturer’s QMS.