Heavy metals are ubiquitously present in the environment surrounding us. Heavy metals containing ingredients such as thimerosal (mercury) and lead acetate were used as cosmetic ingredients in the past. They were also used as reaction catalysts during chemical synthesis and for manufacturing industrial equipment, containers or closures.
- September 21, 2022 Chemicals, Cosmetics Regulatory Services
- September 21, 2022 Regulatory Affairs, Regulatory Software & Services
Regulations stand crucial for any industry that functions in the Life Sciences domain, which is the third most heavily regulated sector after the Aviation & Financial sectors. Non-compliance with regulations comes at a high cost – the patients’ lives, heavy economic penalties, or loss of reputation. But challenges to this sector comes from various areas.
- September 21, 2022 Pharmaceuticals, Regulatory Affairs
In the European Union (EU), the promotion of medicinal products is governed by advertising laws and regulations.
- September 20, 2022 Generics, Regulatory Affairs, Publishing & Submissions
Advance Therapy Medicinal Products (ATMPs) are novel drugs that meet patients’ specific needs. But they drastically increase the cost of treatment. Generic alternatives provide relief in terms of treatment cost with a quality drug of similar effectiveness.
- September 2, 2022 Medical and Scientific Communication, Regulatory Medical Writing
Social media and other communication technologies are excellent instruments for bringing attention to public health issues and solutions. In addition, these contemporary tools are employed to disseminate misinformation and conspiracies regarding various subjects, such as vaccinations, genetically engineered organisms, climate change, and, most recently, the COVID-19 pandemic.
- September 1, 2022 Medical Devices
Labeling is an integral part of marketing medical devices. The label is a piece of information affixed with the device and/or packaging in a human-readable format. The main purpose of labeling is to provide safety information to users who can be healthcare professionals, consumers, or any other relevant person.
- September 1, 2022 Pharmaceuticals, Regulatory Artwork Services
The rise in Tracking and Tracing (T&T) systems in the pharmaceutical industry can be attributed to the development of novel and patient-centric medicines. Over the years, T&T systems have improved medication for patients by transforming product handling processes without a quality compromise until it gets dispensed by integrating supply chain operations and technology use.
- September 1, 2022 Generics, Pharmaceuticals, Publishing & Submissions
In 2023, about fifty-one (51) drugs will get off-patented in the United States, opening the gates for generic drugs to claim a share of the expected expired drugs. Tracking the expiration of these drugs will help assess business opportunities and refine market entry strategies.
- August 30, 2022 Medical Devices
The 510(k)-clearance program, also known as Pre-Market Notification (PMN), is US FDA’s device review pathway to ensure safe and effective entry of medical devices into the US territory. US FDA requires manufacturers of the majority of Class II devices and a few Class I and III devices to obtain 510(k)-clearance.
- August 29, 2022 Regulatory Software & Services
On July 28, 2022, the EMA released an incremental update to the IDMP-SPOR implementation guide (IG). The latest version, 2.1.1, addresses a few gaps in product data definition, including corrections and clarifications.