Built-in quality systems in regulated contract research organizations (CRO) conducting bioequivalence studies: a regulatory science perspective

As contract research organizations are now familiar with GXPs and have become more popular for conducting bioequivalence studies, it is very important that the sponsor has the assurance that the study has been conducted not only to the highest standard of science but also in compliance with regulatory requirements. The dynamic role of quality personnel requires alert knowledgeable people to recognise all the issues which arise and take the proper actions—experienced persons can detect and rectify these. On the basis of equality, for quality system personnel and scientists a firm grasp of regulatory science is needed to succeed. It must be remembered that compliance is monitored by adherence to regulatory standards, whereas the regulatory bodies review the appropriately implemented regulatory science principles. Electronic supplementary material  The online version of this article (doi:) contains supplementary material, which is available to authorized users.