Imagine working on a new drug to treat a devastating disease. After years of hard work, you've finally gathered the data you need to submit a regulatory submission to the FDA. But then, you realize that your electronic records and eSignatures don't comply with 21 CFR Part 11. This is a scenario that no one wants to find themselves in. The world of regulatory compliance is complex and ever evolving.
- October 6, 2023 Regulatory Software & Services
- October 4, 2023 Pharmaceuticals, Compliance, Audit and Validation
Navigating the Path to Success: Ensuring a Smooth FDA Inspection
For companies operating in industries regulated by the U.S. Food and Drug Administration (FDA), the prospect of an upcoming inspection can often be met with a mix of anticipation and apprehension.
- October 4, 2023 Pharmaceuticals, Compliance, Audit and Validation
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, 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.