Richmond Pharmacology ensures your regulatory submissions meet the requirements for global regulators.

Our experienced Advanced Research Science team will compile all necessary documentation, including writing the information for volunteers, informed consent form and completing the online 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 HRA approval for a specific NHS 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.

We ensure your regulatory submissions will fulfil the requirements of the FDA, MHRA, EMA and PMDA.

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Latest news

Director of Operations, Keith Berelowitz, has been appointed as the Research Ethics Committee Chair for the Health Research Authority.

January 19, 2023
Keith Berelowitz will be responsible for ensuring that all ethical possibilities are explored in relation to new research.
Read more

Unlocking the potential of data sharing

January 4, 2023
Dilshat Djumonov explores how GDPR is central to protecting private information while presenting unique challenges to the pharmaceutical clinical trials industry.
Read more

Events

13th International Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions

Sunday, June 4th to Tuesday June 6th 2023
Exchange research-based knowledge on drug-drug interactions (DDIs) among all interested stakeholders from pharmaceutical industry, regulatory authorities, academic and health care delivery backgrounds and perspectives.
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