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.

Reviews and tracks regulatory and clinical trial documentation to ensure compliance with all applicable GCP and regulatory guidelines

Regulatory submissions

We have experienced people to manage your submissions in compliance with all local regulations.

Prepares, tracks, and maintains clinical trial applications to the regulatory authorities

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.

Works closely with the medical monitor to ensure that safety information is appropriately collected, evaluated, and reported, including serious adverse events and other significant safety events