During the period when Covid struck hard to the whole world, we were searching for only words which could give us hope to survive such as “Efficacy” and “Risk”. Vaccines were looked at for their efficacy and to understand about their risks by everyone.
- September 29, 2023 Medical and Scientific Communication
- September 28, 2023 Food and Food Supplements, Regulatory Affairs
Food and beverage manufacturers in the European Union (EU) keep a close eye on the Regulatory landscape, and it is evident that various areas are garnering the regulators’ attention, from High-Fat, Sugar, and Salt (HFSS) laws to novel food regulations.
- September 28, 2023 Medical Devices, Regulatory Affairs
The biggest challenge that creative medical device Research and Development (R&D) programs face is that of balancing clinical evidence with early patient access. To address this, a new review system was proposed in Japan, to pace up device clearance while maintaining safety and efficacy. This benefits patients who are inflicted with life-threatening diseases that lack effective treatments.
- September 28, 2023 Medical Devices, Regulatory Affairs
As technology continues to advance, so do the medical devices that are used to sustain life. While in South Korea, various types of medical devices capable of communication have been developed, the development is accompanied by the risk of cybersecurity threats such as hacking of medical devices and information leaks.
- September 28, 2023 Medical Devices, Regulatory Affairs
Software as a Medical Device (SaMD) is an emerging category of medical devices that has been experiencing rapid growth in recent years. This category of devices includes medical device software applications designed for medical purposes, such as diagnosis, disease prevention, treatment, and monitoring.
- September 27, 2023 Cosmetics Regulatory Services, Regulatory Affairs, Regulatory Labeling
The cosmetic industry of Hong Kong is thriving, and it offers a diverse array of beauty and personal care products. Regulations and standards are in place to ensure the safety and efficacy of these products. Manufacturers and importers must understand the cosmetic Regulatory scenario in Hong Kong to ensure consumer protection.
- September 21, 2023 Regulatory Software & Services
AI is the new buzzword, and it does not seem like its buzz is getting any fainter any time soon. We all know that Artificial Intelligence (AI) and Machine Learning (ML) have been a transformative force across various industries, and the medical sector is no exception. In recent years, AI/ML has made significant strides in revolutionizing Regulatory operations within the medical industry.
- September 20, 2023 Pharmaceuticals, Regulatory Labeling
The development and approval of medications for children is a critical aspect of pediatric healthcare. However, due to ethical and practical considerations, clinical trials involving children are often limited. As a result, pediatric drug labeling plays a crucial role in ensuring the safe and appropriate use of medications in this vulnerable population.
- September 20, 2023 Regulatory Artwork Services, Regulatory Labeling
Quality is paramount in the pharmaceutical industry. From research and development to manufacturing and distribution, every step must adhere to the highest standards of accuracy to ensure patient safety and Regulatory compliance. One of the major aspects of this intricate process is pharmaceutical labeling, specifically the artwork flow.
- September 20, 2023 Pharmaceuticals, Regulatory Artwork Services
In the highly regulated pharmaceutical industry, the production of medicines and related products requires meticulous attention to detail and compliance with various regulatory guidelines. One critical aspect of pharmaceutical production is creating, approving, and managing artwork, including labels, packaging, and promotional materials.