Services

Our consultants combine their pharmacovigilance expertise with information technology to continually stay on top of current global regulations, business issues and trends in the industry to, in turn, help companies meet their best practices for drug safety. We offer support for all stages of the software implementation lifecycle.

Compliance Services

Life Science companies are subject to many different, and often confusing worldwide government regulations. November Research Group can help companies ensure their systems and business processes are implemented and managed in compliance with all applicable regulations. We can perform system and process audits of vendor supplied and legacy systems, and provide assistance in addressing any compliance issues that are found.

Additionally, we can work with companies to develop and implement compliant processes through the development of industry accepted Standard Operating Procedures for information technology and safety data management. Areas generally included as SOP topics include: SAE reporting, clinical data reconciliation, backup and restore, disaster planning and recovery, IT change management and many others.

Our consultants are experience with worldwide regulations including 21 CFR Part 11 for the United States, EMEA guidelines for Europe, and ICH guidelines for the United States, Europe and Japan.