Submission and Specialty Filing

Partner with our Oncology-focused regulatory experts

TD2’s expert regulatory team efficiently compiles, validates, and publishes regulatory documents and dossiers in eCTD format while facilitating submission to regulatory agencies. Our experienced team will guide and manage the submission process to facilitate an on-time filing. By handling the entire regulatory process, we work tirelessly to get your treatment to the right patients and ultimately approved.

IND Filing

  • Template documents, project timeline management and Summary preparation
  • Technical regulatory writing support for Modules 1 through 5
  • IND compilation, electronic Common Technical Document (eCTD) publication, validation, and regulatory submission
  • Submission maintenance for regulatory compliance
  • Annual Reports
  • Safety reporting
  • Regulatory point of contact with FDA
  • US Agent for foreign clients

Specialty Filing

  • Pre-IND and INTERACT submissions
  • Orphan Drug Designation
  • FDA Expedited Programs such as:
    • Breakthrough Therapy Designation
    • Fast Track Designation
    • Sub part H: Accelerated Approval
    • Priority Review Designation
  • Compassionate or Emergency Use
  • Other programs such as Real Time Review (RTOR), Assessment Aid Pilot Project and Pediatric Study Plans

Regulatory Consulting

TD2’s Regulatory Affairs Team engages Oncology drug development experts and strategists with proven track records of success. We leverage experienced, oncology-focused medical writers, regulatory experts in CMC, pharmacology, and toxicology, as well as regulatory program managers to provide a customized approach across all areas of drug development.

Learn more about our Regulatory Services.

Contact our experts to help advance your development program with our trusted translational regulatory consulting team.

Contact Us

Get Started.

Have questions about how TD2 can assist with your regulatory needs? Reach out to our
expert staff today to get started.