In/Out-licensing DD

In/Out-licensing due diligence

OCS supports companies with

  • Pre-IND/IND interface
  • Assessment of completeness of the pre-IND package and IND to ascertain
  • Likely outcomes with the FDA
  • If the IND package and associated FIH protocols contain sufficient to ensure patient safety, to allow a decision to made on go or no-go into mid-stage clinical development
  • Early-stage clinical development
  • Assessment of protocols and execution to allow a decision on dose, likely safety profile and potential clinical benefit in indications that would support a lean registration study package.
  • Pre NDA submission
  • Assessment of the quality and completeness of the data package to be submitted to regulatory authorities, including identification of potential weak points and planning on mitigation strategies.

Learn more about OCS

Contact our team today to discuss how OCS can support your organisation with a wide range of services