Providing proven expertise in:

  • Electronic Common Technical Document (eCTD)

  • Document templates and template development

  • Electronic Document Management Systems (EDMS)

  • Desktop publishing, MS Word remediation, PDF remediation, report publishing

  • Submission publishing services

  • eCTD readiness assessment

  • Submission process development

    1. Submission product planning

    2. Quality control checklists for individual documents and submission sequences

    3. Electronic and paper submissions

    4. Investigational, marketing, and post-marketing submissions

    5. Review and approval

    6. Standard operating procedures

    7. Quality assurance + quality control

  • EDMS and submission publishing system selection, implementation and management

  • Computer system validation (IQ, OQ, PQ/UAT)

  • eCTD validation services using GlobalSubmit Review & Validate