Analytical Testing




 

 

 

PCI Synthesis Capabilities

Discover it Here. Make it Here.

PCI Synthesis Inc. is a custom chemical manufacturer of new chemical entities (NCE’s), generic API’s, 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 Part 11 7a 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.

Custom Development and Manufacturing

Process Research

  • Gram to Kilogram Scale
  • Synthetic Route Evaluation
  • Custom Synthesis

Process Development

  • Kilogram to Multi-ton Scale
  • Process Technology
  • Custom Manufacturing

Commercial Manufacturing

  • Clinical Trials
  • Scale-up
  • Bulk Quantities

PCI's Core Technologies Include:
  • Alkylations
  • Aminations
  • Brominations
  • Nitrations
  • Carboxylations
  • Friedel Crafts Reactions
  • Grignard Reactions
  • Hydrogenations
  • Oxidations
  • Chiral Synthesis
  • Reductive Alkylations
  • Reductive Aminations
  • Esterifications
  • Reductions
  • Surface Chemistry on Polymer Resins


PCI Synthesis is dedicated to providing the best customer service
through dedicated Project Management.

We Provide:

  • Kick-off Meetings (Internal and External)
  • Detailed Project Plan, Agreed Milestones, and Deliverables
  • Weekly Tracking and Regular Reporting
  • Communications Based on Transparency and Accountability
  • Increased Flexibility and Responsiveness

Why choose PCI Synthesis?

PCI’s small company environment yet big company
capabilities give PCI the ability to:

  • Adapt and respond quickly and effectively to customer’s needs
  • Deliver products on time and within agreed specifications