Full support for GCC eCTD and NeeS
Mono Software and PRS announce the new release of the eCTD Office suite, widely used eCTD (NeeS / VNeeS) publishing solution for EU, US (FDA), CA (HCSC), CH (Swissmedic), Australia (TGA) and New Zealand (Medsafe) eCTD / NeeS / VNeeS electronic submissions.
The Drug Sector at the Saudi Food & Drug Authority (SFDA) has recently declared its plan to implement the Electronic Common Technical Document (eCTD).
Companies wanting to prepare e-submissions for SFDA (Saudi Food & Drug Authority) can benefit from the easy-to-use, affordable, feature packed tool many EU/US located companies are using for years (enjoying "stellar support"): eCTD Office!
eCTD Office fully complies with the Guidance for Registration and the GCC Module 1 Specifications guideline which are available at the SFDA website.
By using the GCC (SFDA) eCTD Compiler, a part of eCTD Office, several topics including easy electronic submission generation, lifecycle management and consistency with the eCTD XML DTD and GC regional validation rules (for all Gulf countries, including: United Arab Emirates, Kingdom of Bahrain, State of Kuwait, Sultanate of Oman, State of Qatar, Kingdom Saudi Arabia and Republic of Yemen) are addressed and solved.
Even if you already have an eCTD/NeeS/VNeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission.
Invest only 45 minutes of your time and request a live personalized web demo of eCTD Office.