Medical Writing Publishing & Submissions

    CTI's Medical Writing team is comprised of experienced individuals with advanced degrees including PharmDs, MDs, and PhDs. Our medical writers work routinely with our functional departments to ensure regulatory documents are developed to be scientifically, methodologically, and operationally sound.

    Regulatory Submissions & Applications

    CTI has continued proven success in numerous approved drug and device applications. We regularly prepare international regulatory submissions, including:

    • 510(k) premarketing submission
    • Biologic License Application (BLA)
    • Clinical Evaluation Reports (CERs)
    • Pre-Investigational New Drug (Pre-IND)
    • Investigational Device Exemption (IDE)
    • Investigational New Drug (IND)
    • New Drug Application (NDA)
    • New Drug Submission (NDS)
    • Pediatric Investigation Plan (PIP)
    • Premarket Approval Application (PMA)
    • Risk Evaluation and Mitigation Strategy (REMS)
    • Supplemental Biologic License Application (sBLA)
    • Supplemental New Drug Application (sNDA)
    • Systematic Literature Reviews

    eCTD Publishing

    Serial submissions to the IND include but are not limited to:

    • Uploads of regulatory archives of US Food and Drug Administration (FDA)/European Medicines Agency (EMA) submissions
    • Ongoing guidance and foresight to keep sponsor aware of required updates
    • Publishing and validation of submission in eCTD format

    Clinical Study Reports

    CTI routinely prepares Clinical Study Reports (CSRs) as part of our work for our sponsors. We work closely with sponsors to ensure accurate data presentation and interpretation, strict adherence to regulatory guidelines, and sponsor requirements.

    Our group of medical writers and research scientists will quickly analyze data and present it in a meaningful way, ensuring a high quality study report. We have an independent Quality Assurance team that ensures quality is the leading factor in all of our services and is reflected in all of our submissions to regulatory authorities.