UL helps clients meet stringent demands for the safety, effectiveness and quality of over-the-counter (OTC) and pharmaceutical products.
OTC and pharmaceuticals are heavily regulated, and increased recalls bring scrutiny and influence consumer confidence. We can help you ensure the purity, potency and quality of your brands.
UL’s certified testing laboratories provide the critical checks required to help protect public safety and brands—from testing the purity and potency of raw material ingredients and finished products to verifying compliance with strict regulatory requirements, assessing a product’s use, safety and effectiveness, and measuring consumer acceptability. Our OTC and pharmaceutical quality assurance services include:
- Pharmaceutical and OTC testing
- Audits, including capacity, quality assurance and post-market quality system verification
- Consulting, including consumer studies and human factors engineering
The benefits of working with UL
UL’s regulatory affairs consultants, microbiologists, chemists and human factors specialists provide cost effective quality assurance solutions. Our microbiological, analytical, physical, contamination and active ingredients testing services forraw materials and finished products verify compliance with regulatory requirements. We also:
- Review product use, safety and effectiveness
- Measure consumer acceptance
- Perform regulatory label reviews
We use recognized methods to test products for compliance to international, federal and regional regulations. The services we offer include pharmacopeia testing to U.S. Pharmacopeial Convention, European Pharmacopoeia and Japanese Pharmacopoeia standards. We also provide compliance testing to U.S. Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs).
Our regulatory expertise
UL provides clients with unique insights into regulatory investigations. For more than 13 years, UL has partnered with the FDA’s Office of Regulatory Affairs, to provide training, documentation and learning systems used by more than 36,000 global, federal, state and local investigators.
Our human factors engineering (HFE) advisory service helps product developers ensure the interactive quality of their products. Recent engagements have focused on:
- Lowering the risk of medication errors by making container labels more legible and packages easier to distinguish from each other
- Developing quick reference cards and instructions for proper drug reconstitution
- Conducting formative and summative usability tests to determine the use-safety and effectiveness of combination products
- Helping companies develop and implement HFE procedures as well as train their in-house personnel on HFE processes and design practices