Regulatory Submissions Consulting
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.