What is GDPR? As a US based, small company, an EU law took some time to hear about. But once we did, we knew we needed to work on being compliant. Here are some lessons learned:
As a CMO, Singota has chosen a cross-functional staffing model, spanning the functions of sampling/dispensing, formulation, filling, and finishing. Cross-functional staffing entails cross-training so that each employee can make the most of the skills they bring to the company, while acquiring new skills and perspectives.
When a pharmaceutical company engages a Contract Development and Manufacturing Organization (CDMO) to provide services, the most fundamental assumption is that the CDMO adheres to Good Manufacturing Practices (GMP). What entitles the CDMO to make that promise? The short answer is, it conducts regular audits of its own staff and business processes.
A CDMO for pharmaceutical companies will transport, store, test, process, fill, and package many different chemicals. Before a new chemical is brought into the facility, it is important to work closely with the client to evaluate the material from an environmental health and safety (EHS) perspective.
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