Regulatory Affairs

Biotrial formulates study designs that align seamlessly with your developmental needs, all the while ensuring the efficient execution of the studies. Our commitment to delivering top-notch regulatory assistance assists you in achieving essential preclinical and clinical study milestones with the utmost quality.

Biotrial’s regulatory group helps sponsors navigate efficiently in a more complex regulatory environment. They can provide regulatory consulting services (FDA pre-IND meeting or EMA scientific advice support) and manage FDA IND, EU CTIS, and non-EU  Competent Authorities (CA) and the Ethics Committees (EC) and Institutional Review Board (IRB) submissions


Regulatory submission

The FDA Investigational New Drug (IND) application and EU Clinical Trial Application (CTA) can be prepared by the Biotrial regulatory officer and validated by the sponsor.

The FDA IND, EU Clinical Trials Information System (CTIS), or non-EU CA submissions are managed by the Regulatory Affairs department.

IRB / EC submission

The submission file to the central/local IRB or Ethics Committees in non-EU countries is prepared by the Clinical Project Manager in charge of the study.

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Medical Writing Support

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CTA application Support in the EU :

  • Investigational Medicinal Product Dossier (IMPD)
  • Investigator Brochure (IB)
  • Development Update Safety Report (DSUR)
    • Writing
    • Review
    • Updates

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