In the chemical industry, consumer product safety reigns supreme. Yet, even the most diligent manufacturers can face unforeseen circumstances that lead to product recalls. Whether it's a labeling error, a potential hazard, or non-compliance with regulations, navigating a recall can be daunting.
- March 14, 2024 Chemicals, Regulatory Affairs
- March 7, 2024 Publishing & Submissions, Regulatory Software & Services
The fast-evolving and dynamic environment of the pharma industry calls for an equally active and quick technology. There is a rise in compliance technology due to various factors like robust regulatory adherence and efficiency in medical operations.
- March 5, 2024 Regulatory Artwork Services
Navigating the intricate world of Regulatory artwork can feel like walking a tightrope. One misstep, one non-compliant label, one inaccurate diagram, and the consequences can be severe. Delays in product approvals, costly fines, reputational damage - the price tag of non-compliance can quickly spiral out of control.
- March 5, 2024 Regulatory Artwork Services
The pharmaceutical industry finds itself amidst a dynamic and ever-evolving Regulatory landscape in 2024. Navigating these shifting currents necessitates a focus on compliant and effective artwork, which serves as a critical tool for ensuring both Regulatory adherence and brand success.
- March 5, 2024 Publishing & Submissions, Regulatory Software & Services
In a recent development, the Therapeutic Goods Administration (TGA), Australia has updated its guidance document titled “eCTD AU Module 1 & Regional Information,” making crucial changes to Module 1 v3.1 while adopting the International Council for Harmonization’s (ICH) electronic Common Technical Document (eCTD) v4.0 specification.
- March 4, 2024 Food and Food Supplements
Singapore’s food industry is currently undergoing a major Regulatory transformation, particularly with respect to infant nutrition. The Singapore Food Agency (SFA) has proposed a set of amendments, with a specific focus on infant formula additive regulations, aiming to elevate the safety and quality standards of infant nutrition products.
- March 4, 2024 Medical and Scientific Communication
In the pharmaceutical and healthcare domains, advertising or promoting the products is vital yet challenging due to the regulatory complexities that pharmaceutical companies must handle.
- February 29, 2024 Pharmaceuticals, Regulatory Affairs
Are you stepping into the world of pharmaceuticals in Brazil? Have you ever wondered how medicinal products /drugs are approved in the country? Get ready as we unveil thirteen (13) must-know Frequently Asked Questions (FAQs) on the drug approval process in Brazil.
- February 27, 2024 Medical Devices, Regulatory Affairs
Clinical trials form a critical phase in the development and approval of medical devices. They provide the necessary evidence to demonstrate the safety and efficacy of a device before it can be marketed. The United States Food and Drug Administration (US FDA) sets stringent requirements for conducting clinical trials to ensure that the data collected are reliable and that patient rights are protected.
- February 27, 2024 Medical Devices, Regulatory Affairs
As a medical device manufacturer, you must understand and prepare for the United States Food and Drug Administration’s (US FDA’s) inspections to maintain compliance and ensure that your medical device can be marketed and distributed without legal impediments. The US FDA’s Regulatory oversight includes ensuring that devices are safe, effective, and meet the necessary quality standards.