CRO Products and Services
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.
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
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.