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For Pharmaceutical Companies
Regarding minors, drug developers must deal with two layers of reality: the real world and the regulatory view. FDA and EMA approved drugs for “children” separately, defining “children” as <18 years as if they were another species. The EMA demands a "pediatric investigation plan" (PIP) years before marketing authorization application, the FDA an initial pediatric study plan (iPSP) 60 days after the end-of-phase-2 meeting;
I describe the abuse of people in medical research in my scientific publications and books now for several years.1-5 It is numerically the most extensive abuse of humans in medical research since Beecher’s critical article in 19666 and the termination of the Tuskegee study in 1972. This abuse takes place for more than twenty years with the approval of the US regulatory authorities, and since 2007 with the approval of the European Union (EU)..