Regulatory Submissions Consulting

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Planning product submissions can be a significant and complex undertaking. Edmine can help, with expert submissions consulting. Edmine experts provide the strategic guidance and hands-on expertise to help make your submissions initiative a success.

Whether you're creating your first submission or addressing a unique issue, there's a service offering to meet your needs, including:
  • Submissions Planning including resource planning, submission tools and vendor evaluation, staff augmentation and process improvement
  • Submissions Tracking including project management, status monitoring and workflow setup
  • Conversion Services for eCTD and SPL/PIM Labeling including LCR and ERF
  • Assembly & Publishing for paper to electronic, PDF Generation and eCTD to paper
  • Quality Control including document validation checklist, submission validation checklist, proofreading and word-to-word comparison
  • Transmission through the FDA electronic gateway
  • Submission Archival including document management system setup

Put Edmine 's deep submissions experience and knowledge to work for your organization.