Products and Services for Regulatory Publishing Activities

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:

  • eCTD, eCopy, NeeS, CTD, IMPD, CTA, RPS (when available) and paper regulatory submissions
  • Comprehensive up-to-date eCTD/CTD/IMPD/IND Authoring Templates
  • Pharmacovigilance Drug Safety Management and
  • Regulatory Activities management and tracking

515 Consulting Group provides Services supporting the above activities and processes including:

  • Submission Preparation and Publishing (Staff Augmentation or Outsourcing)
  • eCTD Training (eCTD, CTD, paper to eCTD transition, etc.)
  • New FDA Module 1 training
  • Submission Planning
  • Publishing tool selection assistance
  • FDA Electronic Submissions Gateway (ESG) Setup and Testing
  • Paper to eCTD transition
  • Authoring Templates Selection, Customization and Training
  • Publishing Tool Installation and/or Software Validation
  • Customized services are also available

IT Infrastructure

515 Consulting Group’s IT infrastructure is based on secure, powerful and backed-up servers hosted by Court Square Group, the leading hosted server provider in the Life Sciences industry. We use state-of-the art world-class software applications and SharePoint document management.