PHARMACOVIGILANCE

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 was founded by Lee Knoch, M.E. to assist the Life Sciences industry with the complexities of choosing and integrating Regulatory solutions. Prior to founding 515 Consulting Group, Mr. Knoch was the President and CEO of the North American division of EXTEDO, GmbH (formerly known as IABG Life Sciences Solutions). Mr. Knoch started up this division and has first-hand experience with the Regulatory needs of Pharma and Biotech companies and other supporting organizations such as CRO's..