• Automated Regulatory Intelligence (ARI): Keeping you Ahead of the Curve

    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.

    On one hand, the...

  • Global Heavy Metal Limits for Cosmetics – An Overview

    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.

    These heavy metals can be found as impurities (...

  • Green Cosmetics and Sustainable Beauty

    As public awareness of environmental issues is increasing rapidly, many cosmetic companies are engaging their focus on natural and environment-friendly emulsifiers and chemicals to be used in their products. The advantages of ‘green’ beauty products go beyond fashion. Newer research approaches have outlined the amount of toxicity in conventional cosmetics. However, it has been observed that...

  • Social Media and the Role of a Scientific Writer
    September 2, 2022 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. Recent studies...

  • An Exclusive Webinar - Foundation Masterclass: 510(k) Clearance Pathway
    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.

    Annually, more than 500 devices are cleared through the 510(k) program....

  • EMA IDMP-SPOR Implementation Guideline v2.1.1 – A Brief Review

    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.

    The new version enables web-based forms to replace the existing electronic application forms (eAF), making them more efficient. The web-based forms project is called...

  • Medical Writing Trends: 2022-2030

    Medical writing refers to writing scientific documents by specific healthcare professionals for various purposes, including Regulatory submissions. The global medical writing market was valued at USD 3.6 billion in 2021 and is expected to reach USD 8.4 billion in 2030, growing at a CAGR of 10.41%. In 2021, North America ruled the market due to the growing number of drug trials and new drug...

  • Extension Period of an ANDA CRL - An Overview

    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. As a result, pharmaceutical organizations should understand the criticality of Abbreviated New Drug Application (ANDA...

  • Medical Device Labeling Compliance Under the EU MDR 2017/745
    August 18, 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.

    All the global Regulatory authorities have certain labeling requirements....

  • Challenges and Implementation of Pharma T&T (Tracking and Tracing) and Serialization

    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.

    In...

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