Content Migration for a Toxicology and Infectious Disease Testing Laboratory
In order to perform COVID-19 testing, a national toxicology and infectious disease laboratory needed to align its regulatory compliance with its parent company. To meet the objective, the subsidiary had to update its standard operating procedures (SOPs) with content from the parent SOPs that already met CLIA/GMP, GLP, GCP requirements.
Clinical Supply Chain Application Implementation for a Global Biopharmaceutical Company
Documentation for a New Cell Therapies Manufacturing Facility
A global biopharmaceutical company with a wide-ranging portfolio was building a new cell therapies manufacturing facility (CTMF) for cancer treatments. While the company’s IT department was tasked with creating the digital infrastructure to support the CTMF, they did not have the in-house expertise required to write the necessary regulatory documentation to support full compliance with regulations.
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