Due Diligence might be of value for the next milestone or for externalization of the project. It includes everything from evaluation of development programs (including pharmacokinetics, pharmacodynamics, safety and quality), a single clinical study or parts of the quality documentation to assessment of complete dossiers. Assessment of clinical documentation usually includes providing a second opinion on the value of a study in connection with an application for marketing authorisations. This can apply to both completed and ongoing studies. We also work with simulations and evaluations based on interim results to give a probability of significant results.
For generics, we review and assess the quality of the file before submission, to ensure its strength before submission.