PCI Synthesis is a Pharmaceutical Development CDMO (Contract Development and Manufacturing Organization) based in Newburyport, Mass. and is the largest small molecule drug substance manufacturer in New England. A wholly-owned subsidiary of Novacap, PCI Synthesis is also a commercial manufacturer...
According to FDA regulations, employees of pharmaceutical, medical device and biopharmaceutical companies are required by law to be trained in current Good Manufacturing Practices (GMP). Many have a made a commitment to their customers, to their clients and to themselves to make Quality a... Read more
The FDA conducts all establishment inspections based upon a systems approach. The FDA's Systemic Inspection Approach covers Quality, Facilities/Equipment, Materials, Production, Packaging/Labeling, and Laboratory. Compliance Insight conducts audits following this model so that our clients are... Read more
Compliance Insight, Inc is pleased to introduce its biosafety testing consulting services for biologic pharmaceuticals and devices. Pharmaceutical and biotechnology companies may now benefit from a variety of new consultative services including: • sterility, mycoplasma, and viral testing for... Read more