Description: e-Regulatory and e-submission publishing and solutions
publishing (3607) templates (2381) submission (540) regulatory (361) fda (359) ctd (62) ectd (32) 510k (24) lee knoch (10) esubmission (10)
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 is a reseller of world-class Software Solutions for:
515 Consulting Group provides Services supporting the above activities and processes including: