It is the responsibility of a regulatory compliance department to make certain that the regulatory compliance systems in place measure the company’s adherence to the current marketing authorisation(s).

This can be achieved by introducing a schedule of regulatory compliance audits to monitor the system. European Regulatory Affairs Limited can provide the necessary support to, or as, your compliance team by carrying out external system audits on a regular basis.

We can provide updates on all regulatory changes and developments in the EU and UK that may impact on your company in relation to compliance.

In addition, we can assist with Good Clinical Practice (GCP) compliance inspection readiness and attendance. We can make up part of your company response team during or after the inspection, as needed and we can support you when liaising with the competent authorities

“BrePco Biopharma has worked with Alice and her team since the start of our project in November 2009. From obtaining an approved paediatric investigation plan (PIP) for our clinical trial to submitting the marketing authorisation application (MAA) upon trial completion. They possess a deep understanding of the regulatory landscape and their ability to navigate complex regulatory requirements is truly commendable. They worked extensively with us as part of the preparation and conduct of four GCP Inspections.”

– BrePco Biopharma