PCI

About us

A Leading Supplier to the Life Sciences and Process Industries PCI Synthesis is a custom chemical manufacturer of new chemical entities (NCEs), generic APIs, and other specialty chemical products. PCI Synthesis offers a turnkey solution for all the steps needed to develop a final API, including process research, process development, analytical development, process validation, regulatory support, and FDA filing. PCI Synthesis operates two FDA inspected cGMP sites in the greater Boston area. The company has its headquarters and commercial manufacturing facilities located in Newburyport, MA while its small scale manufacturing and R&D facility is located in Devens, MA. PCI Synthesis has the proven ability to navigate the regulatory process with it's cGMP manufacturing status and DMF submissions. The company is harmonized to the ICH guidelines and is ICH Q7A compliant. The company has undergone both general site and pre-approval inspections from the FDA in 2002, 2003, 2004, 2005, and 2006 as well as numerous customer audits. Company Highlights: 1996 Incorporated 1998 Began commercial manufacturing of bulk pharmaceutical intermediates for major pharmaceutical companies. 1999 Began manufacturing Active Pharmaceutical Ingredients 2003 New Research and Development Center opened i…  Click for details>>