515 Consulting Group provides expert advice and systems integration products and services to Pharmaceutical, Biotech and Medical Device companies and third-party service companies such as CROs. We focus on Regulatory Activities necessary to gain drug product and medical device approval by Worldwide National Competent Authorities (for example, the FDA in the USA) such as Submission preparation and publishing, Drug Safety Management and Management and Tracking of Regulatory Activities.
515 Consulting Group's IT infrastructure is based on secure, powerful and backed-up servers hosted by Court Square Group, the leading hosted server provider in the Life Sciences industry. We use state-of-the art world-class software applications and SharePoint for document management.