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Regulatory affairs

How do I ensure high-quality regulatory submissions?

Quotient Sciences’ team possesses an in-depth understanding of the evolving clinical trial regulatory environment in Europe and the U.S., 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 U.K. and U.S. 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.

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