Regulatory and EC Submission


Excellent and well established
contacts to the Competent
Authorities & Ethics Committees


In depth knowledge of
countryspecific procedures


Realistic estimate for timelines to FSFV


Preparing/adjusting the CTA
submission file


Arranging country specific patient
insurance where needed


Completion of CTA file as per
local requirement (local translations,
notary verified certificates etc.)


Arranging timely a date for submission
in those countries where personal
presence is mandatory for CTA submission


Close follow up with Authorities and
client until approvals are obtained


Follow up with Authorities and ECs
as required per law and in agreement
with client