In the dynamic landscape of business operations, maintaining compliance, conducting thorough audits, and ensuring validation are critical processes that organizations must embrace to uphold their reputation, enhance efficiency, and meet regulatory requirements. Two fundamental audit types that play a pivotal role in achieving these goals are internal audits and supplier audits.
- October 4, 2023 Pharmaceuticals, Compliance, Audit and Validation
- October 4, 2023 Pharmaceuticals, Regulatory Medical Writing
Introduction
In the pharmaceutical arena, the assurance of patient safety is of prime importance. Moreover, the ICH guidelines highlight patient safety by upholding a harmonized approach to be followed by countries/ regions.
- October 4, 2023 Pharmaceuticals, Regulatory Medical Writing
In the dynamic landscape of pharmaceutical development, the journey to ensure the equivalence of generic drugs to their reference counterparts is guided by rigorous scientific scrutiny. Bioequivalence studies stand at the forefront of this process, wielding the power to determine whether a generic drug performs on par with its innovator version.
- September 29, 2023 Medical and Scientific Communication
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 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.