RD&C provides a new systemic analysis concept for impurity profiling in pharmaceutical drug process development and impurity related deviation management required in routine drug manufacturing.
RD&C developed a novel systemic analysis concept for impurity profiling and impurity related deviation management in pharmaceutical drug process development and routine manufacturing. Impurity issues are a major challenge for pharmaceutical industry lacking relevant in-house expertise and a holistic view on these issues.
RD&C offers one-stop-shop solutions with customized services and modules including impurity profiling and optimization in early preclinical development within chemistry, manufacturing and control for IMPD applications and drug approval process. Additionally, we provide support on impurity related deviation management for routine drug manufacturing involving identification, analysis, synthesis and qualification of unexpectedly appearing impurities and degradation products. Moreover, our vision is to generate a database consisting of qualified impurity reference standards including Certificate of Analysis, analytic and synthetic methods and a toxicological evaluation.
Neuwaldegger Strasse 35/2/3