Regulatory affairs

Quotient Sciences’ team has an in-depth understanding of the evolving clinical trial regulatory environment in Europe and the US, ensuring the production of high-quality dossiers and a seamless submission and approval process for your Phase I clinical trial application.

Our highly experienced regulatory specialists and scientists prepare, submit, and/or manage:

• Clinical Trial Authorization (CTA) and Investigational New Drug (IND) applications
• Institutional Review Board (IRB)/Research Ethics Committee (REC) submissions
• Administration of Radioactive Substances Advisory Committee (ARSAC) applications for studies requiring dosing of ionizing radiation to human volunteers

Our services also include:

• Writing and reviewing chemistry, manufacturing, and controls (CMC) drug substance and drug product sections
• Writing and reviewing Investigator’s Brochures (IBs)
• Advising on quality, pre-clinical, or clinical data requirements to support Phase I clinical trials
• Providing strategic advice on UK Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA), and US Food and Drug Administration (FDA) clinical trial regulatory processes

We have strong collaborative relationships with IRBs/RECs in the UK and US, with combined in-depth and up-to-date understanding of the clinical trial regulatory environment and requirements, which results in high-quality submissions and fast approvals.