What if you could find an R&D team that was unafraid of the most complex development challenges?
What if you could find a partner that understood the importance of proactive project management?
What if you could find a partner that could take you from discovery all the way through commercialization with one organization?
Over the last decade, more than 100 companies have relied on North America’s leading API manufacturer to help them reach their development goals. We invite you to learn why.
PCI offers you everything you need from initial process research to commercial manufacturing.
We have more than 20 years of experience in chemical manufacturing, which has enabled us to develop deep expertise in custom NCEs, generic APIs, and custom manufactured fine chemicals. PCI combines the responsiveness of a small company with the capacity and capabilities of a much larger one. This unique combination enables us to:
- Adapt and respond quickly and effectively to your development needs
- Deliver products on-time and within agreed specifications
- Offer competitive pricing and a true ease of doing business
Key Company Facts:
- 15 DMF’s (Drug Master File) filed:
•8 Approved/pre-approved
•7 pending, 2 for submission in 2017
•Winner of 14 CMO Leadership Awards
•Winner of Best NCE Manufacturer in the 2016 Healthcare & Pharmaceutical Awards
- -DEA Licensed for Schedule II-V
- -Scaled up 100’s of chemistry processes.
- -2009-2016, 96% of orders delivered on time
- -100+ employees
- -Largest small molecule drug substance manufacturer in New England
Project Management
We believe in communication based on transparency and accountability, and make sure that any issues are brought up immediately.
Our clients routinely tell us how much they value our proactive project management approach.
At PCI, we strive to keep our clients constantly informed about the progress of their projects, and provide them with regular weekly updates on every aspect of the work we are doing. We also make sure that any issues are brought up immediately, so that we can collaborate with our clients to solve the small problems before they grow into big ones.
PCI replaces the frequent communication complexities of dealing with overseas supplier-based solutions with the ready access of a domestic one. Our API manufacturing clients enjoy the ability to teleconference with us during regular business hours, and the ability to meet with us face-to-face on a regular basis. This closer collaboration enables PCI to speed API clients’ products to market in a manner that overseas outsourcing simply cannot.
PCI offers a turnkey solution for all the steps needed for any final API or drug substance manufacturing project, including process research, process development, analytical development, process validation, regulatory support, and FDA filing. PCI already has numerous API manufacturing products in its pipeline, including generics and new chemical entities (NCE’s) and will continue to launch and/or commercialize multiple API’s annually. Our DEA License allows us to develop and manufacture compounds for Schedule II-V.
Our project management tactics include:
- Kick-off Meetings (Internal and External)
- Detailed Project Plans, Agreed Milestones and Deliverables
- Weekly Tracking and Regular Reporting
- Communications Based on Transparency and Accountability
- Increased Flexibility and Responsiveness