In the European Union (EU), cosmetic products play a significant role in the beauty and personal care industry. To ensure the safety and quality of these products, the EU has put in place stringent regulations, including specific guidelines for cosmetic packaging. Cosmetic manufacturers and suppliers looking to market their products in the EU must understand and comply with these requirements.
- October 9, 2023 Cosmetics Regulatory Services, Regulatory Affairs
- October 9, 2023 Pharmaceuticals, Regulatory Artwork Services
Regulatory artwork compliance is of utmost importance in the pharmaceutical industry to ensure patient safety and adherence to Regulatory standards. Pharmaceutical companies must navigate complex Regulatory requirements and maintain compliance throughout the artwork management process.
- October 9, 2023 Pharmaceuticals, Regulatory Artwork Services
In the pharmaceutical industry, Regulatory artwork plays a crucial role in ensuring compliance, quality, and patient safety. The creation and management of artwork for packaging and labeling must meet stringent requirements set by Regulatory bodies such as the FDA.
- October 6, 2023 Regulatory Software & Services
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 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.