Bioequivalence and Bioavailability Forum

If a trial is conducted in India by a manufacturer from India for a sponsor from non-India location, who should be releasing the IMPs? Should it be the QA or the QP of the company? Is Indian regulatory body satisfied with QA release for clinical trial in India? What should an Indian CRO expect from an overseas sponsor in terms of the person (QA/QP) who does the batch release?

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Edit: Please see the Forum’s Policy! Don’t expect too many answers given your laconic posting style. [Helmut]