UL offers the pharmaceuticals industry the critical testing, consulting and research services necessary to support its drive to provide safer, more effective products. Our global presence and regulatory knowledge, teamed with our scientific expertise, help open unrestricted access to the world market. Our trusted reputation can provide a key quality differentiator for pharmaceutical products.
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.
Our research services help manufacturers understand and meet consumer needs and preferences. We also assist the pharmaceuticals industry in efficiently managing the global supply chain with a full range of materials, capacity and quality assurance auditing, advisory, monitoring and training services.
For those medicines delivered via a proprietary device, UL’s human factors engineering experts can help a pharmaceutical manufacturer ensure the device’s safety and effectiveness. We can also help a manufacturer establish a high-quality human factors engineering program and associated procedures, which might call upon our experts to provide special training to ensure successful implementation.
Once the product is on the market, UL supports post-market quality system verification through mock audits to regulatory requirements.
Hundreds of pharmaceutical, biotechnology and biologic facilities worldwide rely on UL to deliver regulatory compliance, product safety and workforce productivity in a fast-changing global economy. We support our customers through services tailored to the specialized requirements of clinical trials, manufacturing operations, sales and marketing, and post-marketing activities.
Our combination of educational resources, technologies and services provides a robust and cost-effective solution that enables enterprise-wide knowledge transfer and facilitates compliance with U.S. and global regulatory agencies and organizations, including the FDA, EMEA, ICH and ISO.
We have a Cooperative Research and Development Agreement (CRADA) with the U.S. Food and Drug Administration. Through this unique partnership, UL has provided the online training, documentation tracking and 21 CFR Part 11-compliant platform used to certify and train over 36,000 FDA inspectors globally.