Due Diligence


“I am interested in licensing a drug currently in development and need to perform due diligence to establish if the risks and challenges involved in the manufacturing could be surmountable within an achievable budget.”


> Review CMC-related files held in licensor’s on-line data room

> Identify key risks either to usability of existing drug or to future manufacturing

> Prepare a list of questions seeking further information from licensor

> Challenge licensor’s CMC team on key risks to try to uncover gaps or solutions

> Prepare a risk analysis assigning risk priority and risk mitigation options

> Contribute to overall due diligence presentation

> Optional: develop a high-level plan for taking the CMC activities to the next development milestone


A due diligence package typically spans a period of up to 1 month to complete the scope once access to the data room is established.