UL supports the OTC (over-the-counter) industry with testing, consulting, inspections and audits aimed at protecting public safety and helping manufacturers support their drive to provide safer, more effective products.
Our global presence, expertise gained from over a century of safety science experience and regulatory knowledge help speed market access for safer OTC products. Our regulatory consultation services help brands manage risk and understand the compliance demands in all their target markets. We also provide the knowledge needed to meet consumer expectations and efficiently manage the global supply chain.
UL performs pharmacopeia testing to USP, EP and JP standards, and compliance testing to DSHEA and FDA cGMPs. We offer microbiological, analytical, physical, contamination and active ingredients testing, among other services.
For those medicines using delivery mechanisms, UL human factors engineering experts provide experienced research, design, evaluation and training for OTC pharmaceutical manufacturers, including adverse event analysis and user research.
Once the product is on the market, UL supports post-market quality system verification through mock audits to regulatory requirements.
UL also provides content and online learning management systems that afford the necessary training and qualification to comply with industry regulations. For more than 13 years, under a unique partnership with the U.S. Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA), UL has provided the online training, documentation, tracking and 21 CFR Part 11-compliant learning system for ORA-U, the FDA’s virtual university.
Since that time, over 36,000 federal, state, local and global investigators have used this solution. In addition to the learning technology, UL has developed several hundred courses either with or used by the FDA for training those investigators.