Service Offerings EDMS and Submission Publishing

  • eCTD readiness assessment & gap analysis

  • eCTD training targeted at company leadership, regulatory strategists, regulatory operations, information technology

  • eCTD quality control & validation for all ICH regions

  • eCTD publishing systems selection, implementation and validation.

  • EDMS publishing systems selection, implementation and validation.

  • eCTD submission publishing services

  • eCTD submission publishing staff augmentation

  • Electronic Document Management System (EDMS) selection, implementation and validation

  • MS Word templates, toolbars, and user training for eCTD document authoring

  • EndNotes implementation, configuration, and training

  • Label conversion to Structured Product Labeling (SPL) standards for drug, biologic, device, veterinary, and over-the-counter products