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Nonclinical Development

A comprehensive product strategy and design is the key determinant of a successful Nonclinical program. At Treximo,our consultants provide a breadth of experience within the key areas of CMC, Clinical and Regulatory for the development of biologic, biosimilars, large molecule and small molecule products.

  • Pharmacology and Toxicology program review and strategy development
  • CMC Consulting
  • Vendor Program Management
  • Gap Analysis and due diligence
  • Global Dossier Development and Submissions
  • FDA Meeting Preparation & Representation (Pre IND)
  • eCTD submission formatting and compilation (IND, IDE and CTA)
  • Gap Analysis Assessments and Due Diligence for existing Nonclinical programs
  • Regulatory Submission Preparation for Pharmacology and Toxicology results
  • Regulatory Affairs Product Registration