If your product must be submitted to the FDA, CDER or the European regulatory authorities, the challenges are complex and ongoing.  The rules and requirements are constantly being updated.  Time in getting your product to the consumer is the most valuable commodity you have.

Knowing the various stages of compliance and your investment in time is e-SubmissionsSolutions expertise.  To see the problems of the future and to work with you to find the answers means fewer delays.

This could be as straightforward as performing an  eCTD readiness assessment and gap analysis.

Your Company may need eCTD training targeted at company leadership, regulatory strategists, regulatory operations or the information technology team.

Part of the submission process is eCTD quality control and validation, can you source this expertise?

Are you ready to make the investment in an EDMS publishing system?  Is investing in house the best way to go or should you be looking at submission publishing services?  There are dozens of EDMS publishing systems to select from – which one fits you?

Has the work load of your eCTD publishing staff meant a slow down in compiling?  Where do you find experienced, qualified on site or remote staff?  Do you have the best tools for your publishing staff?  There are MS Word templates, toolbars, and user training for eCTD document authoring which speeds the process.