515 Consulting Group

515 Consulting Group is an Authorized reseller of several industry-leading solutions to Pharmaceutical, Biotech and Medical Device companies throughout North America. We couple these Solutions with our advice and integration services to ensure that the client is up and running in the shortest possible time with the knowledge and expertise of how to best use these solutions and leverage your investment.

515 Consulting Group provides solutions and services for:

eCTD/CTD/IND publishing (FDA, EMEA, Canada, Japan, Other, NEeS and general Regulatory publishing). 515 Consulting provides these solutions from leading vendors with a hosted or client/server offering. 515 Consulting also takes care of the software validation and training requirements necessary in a Regulated environment

eCTD/CTD/IND/IMPD Authoring Templates. These Template solutions are unique in the industry by including both instructional text gained from regional guidance documents as well as knowledge gained from years of submission preparation and assistance to leading pharmaceutical and biotech companies around the world. A further benefit and also unique to these templates, is that these templates do not require Word macros to be enabled on your PC, thus allowing companies to retain high security levels so necessary in today's virus-prone environment. Accompanying services include template training and template customization

Pharmacovigilance drug safety management based on the E2B and MedDRA standards that enables you to classify, create, review, submit, and maintain Pharmacovigilance data and adverse event reports

Regulatory management and tracking of pharmaceutical product information, medicinal product information, medical device information and associated regulatory tasks and

Review and validation of eCTD submissions using the application that EMA, the European Regulatory Authority, uses to validate submissions made to EMA member countries