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Complexity Begets Collaboration. With new achievements and changes each month – from customized medicines to artificial intelligence and automation – it has become significantly tough for the biopharmaceutical business to keep up. The Analytical Scientist spoke with Jennifer Römer (specialist in mass spectrometric protein characterization at R
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In the course of all these communications, worries have already been lifted that some interpretations on the aspect 11 requirements would (1) unnecessarily restrict the use of electronic technological know-how inside a fashion that is inconsistent with FDA's said intent in issuing the rule, (2) significantly increase the prices of compliance to an
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