Projects

The following projects are ongoing or have been recently accomplished.

 eCTD Publishing

• Parallel submission of large eCTD (800.000 - 1.2 Mio pages) for NCE to EMEA, FDA & RoW
• Managing eCTD lifecycle for NCE in EU CP, US NDA and Canada
• Managing eCTD lifecycle for EU CP (multiple tradenames)
• Initial MAA for EU CP hybrid application in eCTD format
• Baseline and parallel variation sequences for several complex EU DCPs (multiple tradenames, multiple dosage forms)
• Baseline and parallel variation sequences for multiple national procedures
• Various lifecycle submissions for variations, renewals etc.
• Several NeeS packages for EU MRP variations

Document Processing

• PDF processing of study reports (multiple projects for various procedures)
• Bookmarking and hyperlinking of multiple M4 and M5 reports (global pharma)

Consulting

• Workshop on eCTD fundamentals and strategy (biotech company)
• On-site support for eCTD compilation & "how to" training (various)
• Implementation support for a submission management system (mid-size pharmaceutical company)
• eDMS migration project (global pharma)