We have a breadth of experience over decades in Regulatory Affairs which supports a sound understanding and recognition of a tactical and considered approach to planning registration activities.

We support a range of activities to progress early phase development. From preparing, providing input and reviewing the documentation to support clinical trial applications (CTA), clinical trial notifications (CTN) and Human Research Ethics Committee (HREC) submissions.

We offer an extensive range of services which support the interface between clinical activities and regulatory submissions. Whether you need regulatory clinical documentation in the Common Technical Document (CTD) format, or management of a clinical expert to write documents suitable for a regulatory agency, we can help you.