ELECDOC Electronic Pharmaceutical Files Ltd. was a fully owned subsidiary of Pro-Pharma’93 company.
It was established in 1998 with the aim of preparing and using electronic files for drug registration. In 2006 Pro-Pharma took over all the electronic registrations from ELECDOC, the daughter company.
We were one of the pioneers of electronic registration in Europe: we prepared over 100 electronic registration files using the NTA structure and carried out successful registration with all of them.
Since 2003 we compile eCTD files for our customers and for our own purposes. We also compiled NeeS documentations (non-eCTD electronic submissions) but now eCTD format is mandatory in the European Union. eCTD is the only system that can properly handle lifecycle management.
eCTD files are used for
- Document management
- Multiple registrations
- Renewals, Variations, lifecycle management
- Achivation
From 01 Jan 2019 all regulatory activities must be submitted in form of eCTD in all EU countries (please see further information: Important news – „eCTD mandatory”).
We can provide full eCTD documentation compilation (for drug registration, renewal, variation applications) in Hungary and/or EU member countries.