515 Consulting Group is an Authorized reseller of select industry-leading solutions to Pharmaceutical, Biotech and Medical Device companies. We couple these Solutions with our advice and integration services to ensure that our clients are up and running in the shortest possible time with the knowledge and expertise of how to best use these solutions and leverage their investment.
515 Consulting Group provides solutions and services for:
- eCTD, CTD, eCopy, NeeS, IMPD, CTA Regulatory publishing software (FDA, EMA, Canada, Japan and other countries). 515 Consulting provides these solutions from leading vendors with a client/server, desktop or hosted offering. 515 Consulting also takes care of the software validation and training requirements necessary in a Regulated environment
- eCTD, CTD, IND, IMPD, CTA Word 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, 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 software 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 software, medicinal product information, medical device information and associated regulatory tasks and
- Review and validation of eCTD submissions software using the application that EMA, the European Medicines Association Regulatory Authority, uses to validate submissions made to EMA member countries
- Multi-country eCTD (and other) submission validation software.