With the growing complexity and sophistication of medical device software, the Regulatory requirements for their registration are becoming increasingly stringent. In 2022, the National Medical Products Administration (NMPA), China introduced revised guidelines specifically addressing the registration process for medical device software.
- July 24, 2023 Medical Devices
- July 24, 2023 Medical Devices
As digital health startups continue to disrupt traditional healthcare practices, businesses must be compliant with regulations to ensure sustainable success. However, achieving Regulatory compliance can be a complex and arduous task. Thus, startups must adopt suitable strategies that will help them navigate the ever-changing Regulatory landscape.
- July 24, 2023 Medical Devices, Regulatory Affairs
A Quality Management System (QMS) refers to a set of systems and processes that a company adopts to ensure the quality of its products and services.
- July 21, 2023 Medical Devices
The Turkish Medicines and Medical Devices Agency (TMMDA) is the Regulatory Agency/Health Authority (HA) of the Government of Turkey. It acts as the Regulatory authority for medicines, medical devices, health products, personal care products, and cosmetics in Turkey. Recently, the TMMDA has published a guidance document dedicated to withdrawals and recalls of both general and in vitro diagnostics.
- July 20, 2023 Pharmaceuticals, Regulatory Affairs, Publishing & Submissions
Radiopharmaceuticals are pharmaceutical drugs that contain radioisotopes, which are used as diagnostic and therapeutic agents. They target specific organs, tissues, or cells in the human body. These medicinal products can be delivered orally, intravenously, or interstitially, and they form a subspecialty of radiation therapy.
- July 19, 2023 Pharmaceuticals, Regulatory Affairs
Launching a new drug product in the market is a complex and highly regulated process that demands careful planning and adherence to Regulatory requirements. During the drug development journey, conducting a pre-Investigational New Drug (IND) meeting is a crucial opportunity for life sciences companies to engage with Regulatory Authorities and obtain guidance, feedback, and agreement on their drug development plans.
- July 19, 2023 Pharmaceuticals, Regulatory Affairs
Regulatory Affairs (RA) play a pivotal role in ensuring drug products’ safety, efficacy, and quality in the dynamic pharmaceutical landscape. Chemistry, Manufacturing, and Controls (CMC) RA is essential for compliance. It aims to safeguard patient health and promote public confidence in pharmaceutical products by ensuring consistency and quality throughout the drug manufacturing process.
- July 19, 2023 Cosmetics Regulatory Services, Regulatory Affairs, Regulatory Labeling
Understanding labeling regulations is crucial for cosmetic companies looking to enter the Chilean market. Compliance with local requirements ensures product safety and consumer trust.
In this blog, we shall explore the key labeling regulations in Chile that businesses entering the Chilean market must be aware of:
- July 19, 2023 Pharmaceuticals, Compliance, Audit and Validation, Regulatory Affairs
In the heavily regulated pharmaceutical industry, internal Current Good Manufacturing Practices (cGMP) audit processes and efficient audit systems serve as vital control mechanisms, ensuring compliance with myriads of standards and regulations.
- July 19, 2023 Pharmaceuticals, Compliance, Audit and Validation, Regulatory Affairs
Navigating the world of Regulatory Affairs in the Life Sciences industry can be a challenging task. One of the most critical components that organizations must manage effectively is the implementation of Current Good Manufacturing Practices (cGMP) that are compliant with the Quality Management System (QMS).