PCI Synthesis is a chemical manufacturer serving the pharmaceutical, biotech, biopharmaceutical, fine chemical & medical device industries to produce custom NCE’s, generic API’s & other fine chemical products. PCI offers a turnkey solution for all steps needed to develop a final API, including process research, process development, analytical development, process validation, regulatory support & FDA filing. PCI has more than 50 employees and operates two FDA inspected cGMP sites in the greater Boston area. Its headquarters & commercial manufacturing facility is located in Newburyport, MA while its small scale manufacturing and R&D facility is located in Devens, MA. The technological strength of the manufacturing facility lies in its flexibility. Reactor vessels range in sizes from 50 to 2,000 gallons. Reactor vessels can be operated independently or in conjunction with other reactors for multi-step processes. The plant equipment is capable of synthesizing, isolating, and drying batches ranging in size from 5 to 800 kg. PCI Synthesis has the proven ability to navigate the regulatory processes. The company is harmonized to the ICH guidelines and is Part 11 7a compliant.
