The development and market approval of a new drug is a very costly, complex activity that requires the proper coordination of many functions within our company, e.g. Marketing, R&D, Clinical R&D, Technology Transfer, Production, Regulatory Affairs, Quality Control, Quality Assurance, Finance & Controlling, as well as external stakeholders, such as physicians who conduct clinical studies, Clinical Research Organizations (CROs) who assist Octapharma in conducting these studies and regulatory authorities who review and decide upon our applications for marketing authorization, just to name a few.
In order to optimally use our resources and structure the work that needs to be accomplished on our way from preclinical research to preclinical and clinical development and finally submission to and successful approval by regulatory authorities for market access, production and sales, we strive for state-of-the-art project management (PJM). PJM is also a tool we use to create a stimulating and motivating working environment.
When it comes to developing a new drug, the project team formed around the leadership of a dedicated project manager is one of the major keys to success.