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 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 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.

Latest news

Upcoming Event

EUFEMED, 3rd Annual Conference, 28-30 April 2021

28-30 April 2021
Dr Jorg Taubel will co-chair a session on day one, which explores how technology has reduced the risks of pandemic effects on Phase I and II trial performance.
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What 20 years of clinical research has taught us about our industry and the future of drug development

June 9, 2021
As Richmond Pharmacology approaches its 20th anniversary our co-founder and CEO reflects on the developments, regulatory changes, and innovations within the life science industry in an article in the PharmaTimes.
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Do we still need challenge trials with COVID-19?

April 21, 2021
Nir Eyal and colleagues suggested that the initiation of COVID-19 challenge trials in response to the UK governments’ call in 2020 remained relevant and important despite the development of approved vaccines and the introduction of an aggressive, UK-wide vaccination policy.
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Novel rate-controlled fentanyl patch shows promise in phase I clinical trial

April 1, 2021
Our expertise in ethnic differences and access to over 12,000 first generation Japanese volunteers accelerated our ability to provide robust clinical trial data to support future applications of new chronic pain medicines to the Japanese drug market.
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