Regulatory Applications

Richmond Pharmacology will undertake all regulatory matters on behalf of our clients, depending on their requirements. Our experienced project management team will compile all necessary documentation, including writing the information for volunteers, informed consent form and completing the on-line IRAS application form. Richmond Pharmacology can obtain necessary documentation and specialist opinions for ethics submissions, in order to obtain approvals in a timely manner. We work closely with many ethics committees, local and nationwide, and will select an ethics committee based on study needs.

If required, the Principal Investigator will attend the ethics committee meeting to participate in discussions and ensure a smooth approval process.

As well as working with many Phase I ethics committees, we also work closely with our local ethics committee which approves Phase II studies. If required, we will obtain R&D approval for a specific site, a process of which Richmond Pharmacology has extensive experience.

Richmond Pharmacology will also organise and oversee the CTA application to the MHRA if required. We have submitted numerous CTAs to the MHRA on behalf of our clients, typically gaining approval after the first review of the study documentation.