Regulatory Affairs:

Clinical trial registration/licensing

Our experience encompasses obtaining clinical trial approvals and registration of new chemical and biological entities, as well as established active ingredients. We can also provide assistance with post-registration activities, such as variations and renewals.

Regulatory submissions

We have experienced people to manage your submissions in compliance with all local regulations, for example registration of a new product.

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.

Member of the International
Biopharmaceutical Association