In the ever-evolving realm of the Regulatory landscape, staying abreast of the latest FDA requirements in the form of guidelines is paramount for pharmaceutical and biotech companies. The U.S.
- January 18, 2024 Pharmaceuticals, Regulatory Affairs
- January 17, 2024 Medical Devices, Regulatory Affairs
Navigating the complex landscape of medical device regulations can be a daunting task for manufacturers and healthcare professionals. The United States Food and Drug Administration (US FDA) classifies medical devices into different categories, based on risk, intended use, and other factors. Understanding these classifications is crucial for ensuring compliance as well as the safety and efficacy of medical devices.
- January 17, 2024 Medical Devices, Regulatory Affairs
The journey of bringing a medical device to the United States (US) market is a complex process governed by the US Food and Drug Administration (FDA). Manufacturers must understand the US FDA’s Regulatory pathway to ensure that their devices meet the necessary standards of safety and efficacy.
- January 12, 2024 Regulatory Artwork Services, Compliance, Audit and Validation
The world of regulatory compliance is constantly evolving, and the use of electronic regulatory artwork submissions (eRAS) has emerged as a transformative tool. eRAS offer a streamlined and efficient way to submit regulatory artwork, and it provides a host of benefits for both regulators and submitters.
- January 12, 2024 Regulatory Artwork Services
The pharmaceutical industry is highly regulated, and regulatory artwork plays a vital role in ensuring compliance and patient safety. Adopting a more sustainable approach to regulatory artwork is not just a choice but an imperative. However, the traditional methods of producing and distributing regulatory artwork are often unsustainable, both in terms of their environmental impact and their financial cost.
- January 12, 2024 Pharmaceuticals, Regulatory Labeling
In the pharmaceutical industry, labeling errors can have serious consequences, ranging from jeopardizing patient safety to Regulatory non-compliance. Therefore, companies must prioritize error-free labeling to maintain compliance and uphold the highest quality and safety. In the following lines, let us further delve into the importance of error-free labeling and how companies can accomplish the same.
- January 9, 2024 Pharmaceuticals, Regulatory Affairs
In January 2022, the European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) launched the Accelerating Clinical Trials in the EU (ACT EU) initiative. This initiative consists of ten suggested actions for sites, sponsors, and clinical research organizations (CROs) to take over the next three years, leading up to the full implementation deadline in January 2025.
- January 9, 2024 Pharmaceuticals, Publishing & Submissions
The evolution of the electronic Common Technical Document (eCTD) format has reached a critical stage with the introduction of eCTD 4.0. This latest version promises significant improvements in efficiency, data integrity, and accessibility for Regulatory submissions. Lifecycle enhancements and study tagging are two key features of eCTD 4.0 that can greatly benefit sponsors and Regulatory affairs professionals.
- January 9, 2024 Pharmaceuticals, Publishing & Submissions
Ensuring a smooth and efficient Investigational New Drug (IND) Lifecycle Management (LCM) submission requires meticulous planning and attention to detail. One crucial aspect is the compilation and publishing of your submission package. The process demands a high level of accuracy and compliance with regulatory standards.
- January 9, 2024 Pharmaceuticals, Compliance, Audit and Validation
In the pharmaceutical industry, ensuring the safety and efficacy of drugs doesn't end with Regulatory approval. Post-market surveillance emerges as a pivotal phase in public health. This blog explores its critical role and the Regulatory compliance measures that pharmaceutical companies must adopt in the post-approval stage.