Project Description
We worked with a large US drug company to assist in bringing a new novel combination product to the global marketplace. Our consultants audited the clinical program, including review of the Technical Master File (TMF/Dossier), Investigational Brochure (IB), clinical protocols and Informed Consent(IC) for a global trial randomized multi-center clinical trial. We also audited the investigational sites and performed data verification for sites in the US, India, China, etc. The product was CE marked and then approved by the US FDA.