515 Consulting Group is an authorized partner with:
- EXTEDO. 515 Consulting partners with EXTEDO as a reseller of their leading regulatory software applications including
- eCTDmanager, a leading CTD/eCTD/NeeS/eCopy compilation, viewer, validator and publishing tool,
- EURS, the official eCTD review and validation tool for the European Medicines Agency (EMA) and its associated countries,
- PcVmanager, a leading drug safety management application,
- DRAmanager, a leading Regulatory activities management and tracking application and
- GLOBALvalidator, a stand-alone regulatory validation application that supports the validation of pharmaceutical, medicinal and veterinary eSubmissions for a large assortment of countries including the FDA, EMA (and its individual countries), Canada and more.
- e-SubmissionsSolutions.com. 515 Consulting partners with e-submissionssolutions.com, founded by Antoinette Azevedo, a well-respected regulatory professional consultant. Antoinette is one of the authors of the EDM reference model.
- Sage Submissions. 515 Consulting partners with Sage Submissions, the author of the Sage Templates, the leading set of Global Regulatory Word Templates including:
- US FDA CDER and CBER
- US FDA CDRH
- ASEAN
- Health Canada
- European Medicines Agency (EMA)
- Court Square Group. 515 Consulting partners with Court Square Group (CSG) for its hosted managed solutions. In the life sciences industry, CSG is recognized as a leading provider of expertise in quality, auditing and clinical technology services.