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Discovery

Integrated Discovery Platform
From Concept to IND

IND Filing Support

 

Our biologics discovery team has established a complete preclinical research platform and IND documentation and application filing support functions for innovative medicines throughout PCC selection to IND filing and into phase I clinical trials. Key regulatory support functions include establishment of nonclinical studies and safety evaluation, writing of clinical protocols and development plans, registration support and IND submissions.

  • Non-Clinical
    • Pharmacology
    • Pharmacokinetics
    • Dose Range Finding
    • Toxicity
    • Tissue Cross Reactivity
    • Hemolysis test
  • Clinical
    • FIH Study Protocol
    • Clinical Development Plan
    • IB
    • PK/ADA MD & MV
  • IND Filing
    • Regulatory Affairs
    • IND Dossier Preparation
    • Pre-IND Meeting
    • Dossier Submission and Follow-Up
    • Project Management

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