• Due Diligence for in-licensing and out-licensing candidates & proposals to acquire capital funding

  • Comprehensive support for Scientific Advisory Board meetings

  • Expert medical writing, including publication & messaging strategies, NDA document preparation/review

Recent Projects
De Young & Hayden, LLC (DYH)

    "We recently worked with De Young & Hayden to create the CTD preclinical summaries and overview for an important new NDA filing. I am
    very happy to report that the regulatory authorities had very few questions, saving the company much time and money. We are very pleased
    with the results."
  • Trouble-shooting of company plans, processes, and projects

  • Creating,  testing & validating Target Product Profiles, in-depth KOL interviews and marketing research

  • New product assessment and development

  • Design and assessment of  clinical development programs, Risk Evaluation and Mitigation Strategies
    (REMS), safety labeling, and Core Data Sheet (CDS) updating
    "Appreciate your work . . . you were able to dig through the data and find things we had not previously identified."
    Lead Pharmacologist, Swiss Multinational Pharmaceutical Company
    VP of Sales, Medical Device Manufacturer


   

      Supporting Biopharmaceutical Development



     
        De Young & Hayden

We focus on the basic "S-E-C" of biopharmaceuticals:  
competitive advantages involving  Safety, Efficacy, and/or Convenience.  We take an objective, data-driven approach to
science, development, and marketing. That way, we work  to Manage Risk.





Science

Knowledge

Communication

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