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
- 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.
- February 15, 2024 Pharmaceuticals, Regulatory Affairs
In the vast expanse of China's market regulations, the Marketing Authorization Holder (MAH) System stands as a pivotal aspect governing product approvals and market entry. Demystifying this system unveils the keys to navigating China's intricate market landscape.
- February 9, 2024 Pharmaceuticals, Publishing & Submissions
The pharmaceutical industry is witnessing a transformative era where global Regulatory harmonization is playing a pivotal role in streamlining medicinal product submissions. This harmonization is not only facilitating the exchange of information among Regulatory authorities but also enhancing the reliance on assessments performed by global regulators.
- February 9, 2024 Pharmaceuticals, Publishing & Submissions
In the ever-evolving landscape of pharmaceutical and medical device regulation, two buzzwords have risen to the forefront: data integrity and cybersecurity. As Regulatory bodies like the FDA and EMA intensify their focus on these areas, companies within the healthcare sector must adapt to meet the stringent requirements for Regulatory submissions.
- February 9, 2024 Food and Food Supplements
In a bold move to combat deforestation and promote sustainability, the European Parliament and the Council have enforced Regulation (EU) 2023/1115. This blog dissects the intricacies of this regulation and its profound impact on the marketing and export of commodities linked to deforestation, particularly affecting the formulation and trade of food supplements.
- February 9, 2024 Medical Devices, Regulatory Affairs
The medical device industry in Korea has been growing rapidly. This growth is a testament to the quality and innovation of medical devices manufactured in Korea, which are increasingly being exported globally. A critical factor in determining the safety and efficacy of Korean devices is their adherence to Korean Good Manufacturing Practices (KGMP), as recommended by the Ministry of Food and Drug Safety (MFDS).