Quotient Sciences’ team possesses 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 review of Chemistry, Manufacturing and Controls (CMC) drug substance and drug product sections
- Writing and reviewing investigator’s brochures (IBs)
- Advising on quality, preclinical or clinical data requirements to support Phase I clinical trials
- Providing strategic advice on MHRA, EMA and FDA clinical trial regulatory processes
We have strong collaborative relationships with Institutional Review Board (IRB) / Research Ethics Committees in UK and USA with combined in-depth and up-to-date understanding of the clinical trial regulatory environment and requirements, which results in high quality submissions and speedy approvals.
Clinical Pharmacology Services
Whatever Phase 1 clinical pharmacology study you require, at Quotient Sciences you can expect rapid study startup and rapid recruitment.
See real results
Discover how pharmaceutical and biotechnology organisations have achieved success using our clinical pharmacology services.