Our ISAR Bioscience regulatory team has many years of expertise in planning preclinical and clinical development programs. We prepare documents, discuss study plans and results with clinical experts and submit dossiers to regulatory authorities and ethics committees. We are happy to make this expertise available to other teams in academia and the biotech industry.
As part of our service, we draft and finalize the relevant documents and submit them to the relevant bodies. These include, for example, Investigator’s Brochures (IB), Investigational Medicinal Product Dossiers (IMPD) and Clinical Trial Protocols.