Change in IS [Bioanalytics]

posted by Ohlbe – France, 2012-10-12 12:06 (4611 d 21:50 ago) – Posting: # 9402
Views: 2,488

Dear Ketan,

As long as you perform a full validation again (except long-term, bench-top and freeze/thaw stability, if they were obtained with a reliable and validated method), I can't see any reason why the regulatory agencies would refuse your data.

Regards
Ohlbe
—
Regards
Ohlbe

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