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UL helps Life Science organizations meet rigorous compliance demands before and after a pharmaceutical, biologics or biotechnology product reaches the market.
Combine Technology with GCP Expertise
Our combination of technologies, subject matter expertise and curricula developed in collaboration with the FDA drives regulatory compliance, assures data integrity and minimizes risk throughout the dispersed study network.
In pre- and post-market studies, our solutions have enabled compliance training, communications and defensible recordkeeping that minimizes the potential for error, protects study-related compliance data and achieves cost-efficiencies in the management of dispersed study sites. UL has helped clients address:
- Training related to Good Clinical Practices (GCP), Electronics Data Capture (EDC), ethics and safety to comply with FDA, ICH and other regulations laws;
- Protection of patient safety, confidentiality and informed consent;
- Extension of training from sponsors to investigators and study personnel, Contract Research Organizations (CROs), Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs), Investigational Review Boards (IRBs) and regulators;
- Distribution, validation and documentation of all study-related communications including safety notices, regulatory updates and protocol amendments.
Global Regulatory Compliance Learning
Addressing International Regulatory and Corporate Compliance Requirements