How to Prepare for a Successful MDSAP Audit? Your Guide
Preparing for a successful medical device single audit program (MDSAP) audit requires strategic planning, robust documentation, and cross-functional alignment. For manufacturers seeking to demonstrate regulatory compliance across multiple jurisdictions, MDSAP is a...
Global Cosmetic Regulation: Heavy Metal Limit for Cosmetics
Heavy metals, such as lead, mercury, arsenic, cadmium, and antimony, are considered toxic contaminants in cosmetics. While some may occur as unavoidable impurities due to environmental ubiquity, worldwide regulatory bodies enforce limits to mitigate health risks. To...
An 8-Step Guide to Selecting a US FDA agent for Your Company
A U.S. FDA agent is a designated representative required for foreign companies that manufacture, process, or distribute FDA-regulated products. These products, such as medical devices, drugs, or food, should be intended for import into the United States. We have...