Is your organization making the switch to eCTD or are you an industry veteran in pursuit of the most current thinking?
GlobalSubmit is dually committed to the success of its commercial partners and industry participants on all sides of a submission. By sharing the knowledge we’ve accumulated during a decade in the electronic regulatory business, and making available resources prepared by health authorities and influential groups, we facilitate the transfer of information and encourage transparency.
Changes to government regulations and guidance often dictate business processes for life science companies, as do innovations in technologies. Close coordination with international standards bodies such as the International Conference on Harmonisation (ICH) and Health Level Seven (HL7), as well as leading regional health authorities like the US FDA, EMA, Health Canada and Swissmedic, puts us in the unique position to stay on top of such shifts and share the pertinent documents with stakeholders.
This section of our website is centralized repository of educational resources for anyone involved in the regulatory submissions industry, and is updated as information becomes available.
If the resources listed on our website do not fully answer your eCTD questions, please contact firstname.lastname@example.org.