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The BioPharm Team can provide document management, electronic publishing, and electronic submissions services to biopharmaceutical sponsors and CROs. Services include:
- Document quality and process analysis
- Technology and vendor requirements documentation
- Systems evaluations, selection, validation, and implementation of document management and electronic publishing solutions
- Optimization or redesign of existing eSubmission systems and/or related processes
- eSubmission publishing capability
- Documents that can be published include: eNDA, eNDA/CTD hybrids, eCTD, CTD, IND, clinical study reports, investigator brochures, clinical study protocols, and more. Publishing methodology is focused on the integration of documents and supportive data from the outset of the process.
BioPharm Team consultants who offer these services:
Ross Raymond, PA
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