Regulatory Strategy

    Choosing CTI as a partner for strategic regulatory needs adds value to programs by developing realistic plans and strategies that efficiently move programs forward.

    Clinical Development Planning

    CTI offers a dedicated team of regulatory, medical, and operations experts to assist our sponsors in Clinical Development Planning. Our flexible staff is accustomed to partnering with our sponsors to develop plans that are not only sound from a regulatory perspective but also take into consideration the goals of your organization.

    Our long-term relationships with several key thought leaders in our focused therapeutic areas result in knowledge of current trends in research and drug/device development around the world. Drafting a thorough and realistic Clinical Development Plan is a critical early step in the development process, and can lead to a productive platform for regulatory feedback to set your program up for success.

    Interactions with Regulatory Authorities

    Our employees have served on US Food and Drug Administration (FDA) Advisory Panels including Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH), and they continue to frequently meet with regulatory authorities (FDA, European Medicines Agency [EMA], and many others) to discuss our sponsor’s products, regulatory strategies, and innovative pathway designs.

    CTI has established long-term relationships with many key regulatory officials. Our relationships help to facilitate communication and build on expectations of quality products that are scientifically sound and clearly presented. Our team, including regulatory and medical experts, is adept at coordinating effective regulatory interactions and ensuring that the right questions are asked. This propels programs forward and minimizes the risk of study delays and clinical holds due to unforeseen regulatory issues.

    Our interactions with regulatory authorities have included:
    • Advisory committee hearings
    • Clinical development planning meetings
    • End of phase II meetings
    • Issue resolution meetings
    • Pathway negotiations
    • Pre-Investigational New Drug (Pre-IND), Pre-Biologic License Application (Pre-BLA), and Pre-New Drug Application (Pre-NDA) meetings
    • Regulatory authority sponsored public workshops
    • Scientific advice meetings
    • Type A, B, and C meetings

    Regulatory Strategy & Consulting

    In the highly regulated environment of drug development, it is important to evaluate regulatory pathways and obtain buy-in from governing regulatory bodies as early as possible. This ensures speed to market and minimizes the potential for delays.

    CTI has a team of dedicated professionals with more than 30 years in regulatory, clinical, and management experience, including former US Food and Drug Administration (FDA) committee members and individuals with European Medicines Association (EMA) expertise. This background in regulatory strategy and consulting makes us a strong partner for any organization with needs in this area.

    We have negotiated regulatory pathways on behalf of our sponsors with several regulatory bodies around the world, including experience with:
    • Orphan Designations
    • Breakthrough Designations
    • Fast Track Designations
    • Adaptive Design Programs
    • Direct-to-patient Programs
    • Hybrid Programs
    • PRIME Programs
    infinity symbol

    CTI and COVID-19

    Our international teams have been meeting constantly to devise plans and strategies to overcome the challenges presented to us by COVID-19.

    If your program has been impacted by COVID-19, click here