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