Regulatory Consulting and Support

Expert regulatory strategy and support to navigate oncology trial approvals and compliance.

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Clinical Regulatory Services

Expert Regulatory Support

Theradex provides regulatory support and consulting services to emerging biotech companies across a wide range of therapeutic approaches including new chemical entities, cancer vaccines, and biologics including therapies, monoclonal antibodies and oncolytic viruses.

Targeted Therapy

  • TKIs (e.g. RET, BRAF)
  • Other cell signal proteins (e.g. KRAS, AKT)
  • DNA Damage/Repair (e.g. TP53, ATR, PARP)
  • Endocrine therapies
  • Radioligand

Immunotherapy

  • ADC
  • BITE and Bi-specific Ab
  • mAb (e.g. checkpoint inhibitors)

Novel Chemotherapy

  • PEGylated
  • Liposomal
  • Nanoparticle
  • Dendrimer Polymers

Cell, Gene and other Therapy

  • Oncolytic Virus RNA/DNA
  • Bacterial
  • Radiosensitizer
  • Cell
  • siRNA

Cancer Vaccines

  • Peptides
  • Proteins
  • Cell based
  • Tissue based
  • CPI combination

Regulatory Services

  • Regulatory/Development Strategy Consulting
  • National or Central Scientific Advice Meeting Preparation and Attendance
  • FDA Development Cycle Meetings
  • Pre-IND
  • End of Phase I/II
  • Pre-NDA
  • Specialized Therapy Product Development
  • Gene Therapies
  • Cell Therapies
  • Tissue Therapies
  • Application Preparation in CTD Format
  • Pre-IND, IND Application and IND Maintenance
  • Pre-submissions, Package Preparation and Meetings with CDRH
  • Core Document Preparation and Approval- Electronic Submissions
  • Investigational Medicines Product Dossier (IMPD) Preparation
  • Development Safety Update Reports (DSURs)
  • Small to Medium Enterprise (SME) Registration
  • Clinical Trial Applications
  • Pediatric Drug Development Plans
  • New Drug Applications