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MDS Bioanalytical Audits

MDS Pharma is back to profitability after shedding its bioanalytical facility in Montreal. This lab conducted analyses of 100’s of bioequivalence studies. FDA audited the lab several times, effectively shut down the lab and called into question the acceptability of the BE study conclusions that were used to approve many ANDA’s. FDA required the ANDA sponsors to audit every study conducted since 2000. Camargo was selected by some sponsors to perform these audits. In earlier studies (<~2003) we observed many failures to follow SOPs resulting in incorrect data and questionable actions, but the 2004 studies we audited showed excellent compliance.

Since inception, Camargo has conducted an audit of the bioanalytical assay results from all of our preferred bioanalytical labs, including MDS. Clients often wonder if this additional cost is worthwhile. What do you think?