The United States (US) represents one of the largest medical device markets in the world, offering significant opportunities to foreign manufacturers. However, medical device manufacturers seeking to access the US market need to navigate the complex Regulatory landscape of the US Food and Drug Administration (FDA).
- January 23, 2024 Medical Devices, Regulatory Affairs
- January 22, 2024 Medical Devices, Regulatory Affairs
Navigating the Regulatory landscape for medical device registration in China can be a complex process, especially for foreign manufacturers. One of the most critical steps in ensuring compliance with Chinese Regulatory requirements is the appointment of a China agent.
- January 22, 2024 Medical Devices, Regulatory Affairs
The realm of medical devices is one of constant innovation and advancement. However, the journey of a medical device does not end with its entry into the market. Post-market Surveillance (PMS) and reporting are critical components of a device’s lifecycle, which ensure ongoing safety and efficacy for end-users.
- January 19, 2024 Food and Food Supplements, Regulatory Affairs
The landscape of the food and dietary supplement industry in the USA is ever-changing, marked by continuous evolution and the emergence of new dietary supplement trends each year. As we have just stepped into 2024, the Regulatory perspective becomes crucial in understanding the dynamics that will shape the industry.
- January 18, 2024 Pharmaceuticals, Regulatory Affairs
Amidst the biologics and biosimilar Regulatory landscape, the pharmaceutical industry stands on the precipice of profound transformation. The U.S. Food and Drug Administration (FDA) heralds an era with the approval of biosimilars, promising innovative and cost-effective alternatives for a spectrum of diseases.
- January 18, 2024 Pharmaceuticals, Regulatory Affairs
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 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.