Specializing In Small And Early-Stage Partners, Not Just Small Batches

Source: Singota SolutionsBy Jennifer Gray and Eric Graban, Singota SolutionsFor small and/or earlier-stage pharmaceutical companies trying to advance a small-volume drug product through preclinical and clinical trials, the temptation to partner with large, well-known CDMOs for aseptic manufacturing can be alluring. Their reputation as service providers for large pharmaceutical companies, along with their…

Establishing a Remote Audit Process as a CDMO

The effects of the pandemic have been far reaching within the pharmaceutical industry and compliance audits have not been immune. Widespread travel restrictions and adjusted visitor policies have prevented standard onsite audits from occurring. As a CDMO, Singota had to pivot to provide clients with transparent and robust compliance audits. This article will dive into the process of establishing a remote audit process and how Singota implemented various changes to acclimate to the new norm.