Regulatory Affairs
Our regulatory specialists will manage your trial approvals and provide strategic advice to support your decision making during the trial.
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High-quality submissions and fast approvals
Highly experienced specialists in early phase clinical trial applications, leveraging our CMC and clinical expertise.
Quotient Sciences have strong collaborative relationships with IRBs/RECs in the US and UK, and with the Health Research Authority and MHRA in the UK. This allows us to maintain an in-depth, current understanding of the clinical trial regulatory environment and its requirements, resulting in high-quality submissions and fast approvals.
In the UK, we are responsible for about 25% of Phase 1 healthy volunteer trial applications to the MHRA. Our long experience coupled with our high volume of submissions allows us to quickly understand and adapt to the latest thinking at the MHRA and within RECs/IRBs.
Regulatory services
- Management of UK Combined Review applications for regulatory (MHRA) and ethical approval, from initial submission through to end of trial reporting
- Strategic advice on regulatory aspects of trial design and management, including multi-part complex protocols, amendments, and flexible decision-making
- Preparation of CMC dossiers to support UK, EU, and US clinical trial submissions
- Management of applications to the Administration of Radioactive Substances Advisory Committee (ARSAC) for trials involving exposure of volunteers to ionising radiation
- Minimal or full registration of clinical trials in the UK ISRCTN registry
- US Institutional Review Board (IRB) submissions
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