The safety and effectiveness of medical devices are of utmost importance, and continuous monitoring is essential to ensure successful regulation. Techno-vigilance serves as a vital system for identifying and evaluating adverse events related to medical devices.
- August 28, 2023 Medical Devices, Regulatory Affairs
- August 25, 2023 Food and Food Supplements
What is Cultivated Meat?
Cultivated meat, also known as cell-based or lab-grown meat, is produced by growing animal muscle tissue from cells in a bioreactor rather than from traditional animal agriculture. It aims at replicating the taste, texture, and nutritional composition of conventional meat while eliminating the need for raising and slaughtering animals.
- August 25, 2023 Medical Devices, Regulatory Affairs
Renewing a medical device manufacturing license in South Korea is critical for ensuring the safety and efficacy of medical devices in the market. The renewal process can be complex and time-consuming.
- August 25, 2023 Medical Devices, Regulatory Affairs
The General Data Protection Regulation (GDPR) is a comprehensive privacy law enacted in the European Union in 2018. It applies to all organizations that process the personal data of individuals located in the EU, regardless of where the organization is located.
- August 25, 2023 Medical Devices, Regulatory Affairs
The Health Sciences Authority (HSA) is Singapore's Regulatory agency in the sphere of healthcare products.
- August 25, 2023 Medical Devices
When it comes to gaining Regulatory approval for medical devices, manufacturers must navigate a complex and time-consuming pathway. However, there is a powerful method at their disposal – the pre-Request for Designation (pre-RFD) submission. The pre-RFD submission allows manufacturers to seek early feedback from the United States Food and Drug Administration (US FDA) prior to embarking on the official Regulatory process.…
- August 24, 2023 Pharmaceuticals, Compliance, Audit and Validation
In the dynamic business world, maintaining compliance, mitigating risks, and optimizing processes are critical for ensuring sustainable growth. As your organization navigates the complexities of the modern marketplace, a powerful tool that can bolster your efforts is an audit management system.
- August 22, 2023 Pharmaceuticals, Compliance, Audit and Validation
In the world of Pharmaceuticals, ensuring the safety, efficacy, and quality of drugs is essential. To achieve this, pharmaceutical companies must adhere to strict regulations and guidelines set by Regulatory authorities. Change control is a key aspect of maintaining compliance and ensuring the integrity of pharmaceutical products.
- August 22, 2023 Regulatory Affairs, Regulatory Software & Services
In today's world, businesses in regulated industries like healthcare and life sciences need to follow compliance with industry-specific regulations. Regulatory documents serve as vital communication tools with governing authorities, demonstrating adherence to guidelines, ensuring public safety, and supporting critical business decisions.
- August 21, 2023 Pharmaceuticals, Medical Devices
Innovations in drug-device combinations have led to significant advancements in patient care. Drug product(s) coupled with medical devices offer targeted drug delivery, improved therapeutic outcomes, and enhanced patient adherence. However, navigating the Regulatory landscape for drug-device combinations can be complex.