CRO Products and Services
Regulatory Affairs
Clinical trial registration/licensing
Our experience encompasses obtaining clinical trial approvals
and
registration of new chemical, biological entities and medical
devices.
We can also provide assistance with post-registration
activities, such as
variations and renewals.
Regulatory submissions
Our regulatory team includes professionals with over 20
years
of experience
in dealings with FDA.(USA), TPD (Canada) ,
EMEA (European Union).GTA
(Australia and NZ) and similar
agencies in other countries
Safety reporting
Patient safety and regulatory compliance are our primary
concerns when
conducting clinical studies. We work closely
with our client's own drug safety
department to provide
safety surveillance and prompt, accurate reporting of
serious adverse events.