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 as well as other service companies involved in these areas such as CROs. We focus on Regulatory activities such as Submission preparation and publishing, Drug Safety Management and Management and Tracking of Regulatory Activities. Our advice and integration services include preparing for, selecting, implementing, validating and operating e-Regulatory applications including eCTD and (soon to come) RPS solutions. 515 Consulting can also help you with submission planning, publishing tool selection and purchase, paper to eCTD transition, preparing or outsourcing your submissions, electronic or paper (eCTD, NeeS, eCopy, CTD, 510(k) etc). 515 Consulting Group provides solutions and services for:

  • eCTD, eCopy, NeeS, CTD, RPS (when available) and paper regulatory submissions
  • Comprehensive up-to-date eCTD/CTD/IMPD/IND Authoring Templates
  • Pharmacovigilance drug safety management
  • Regulatory activities management and tracking

Our Services include:

  • Submission Publishing (Staff Augmentation and Outsourcing)
  • Submission Planning
  • Publishing tool selection and purchase
  • FDA Electronic Submissions Gateway (ESG) Setup and Testing
  • Paper to eCTD transition
  • eCTD Training (eCTD, CTD, paper to eCTD transition, etc.)
  • Authoring Templates Customization and Training
  • Publishing Tool Installation and/or Software Validation
  • Disaster Recovery Implementation

Additional services are also available.