In its simplest form, the definition of “quality” is “how good something is.” But what exactly does this mean for the life science industry, whose frame of reference is defined by regulations which are often vague and which provide little or no guidance regarding how they should be imple...
You should be willing to partner with EU pharmas to expedite the regulatory process outside US. In China the process is new and Brazil is behind on their gene therapy guidance. However there is the new issue of repeat testing...