Develop a
Pre-IND Packing
Strategy. Expedite Clinical Trial Timelines.

Our Speed Solutions accelerate your drug product through development to commercialization and beyond. Watch our video to find out more.

Is your drug product manufactured outside of the United States?
Do you have milestones for dosing your first patient that could be challenging to achieve as you await your "Safe to Proceed" Letter from the US FDA?

Utilizing PCI Pharma Services’ Pre-IND solutions within our Canadian-based facility (located in Burlington, just south of Toronto), PCI can help expedite your upstream timeline to get you ready for your first patient-in milestones while you await your FDA Safe to Proceed notification and IND number.

How?

Once you have filed for your IND with the FDA, it can take up to 30 calendar days to receive your Safe to Proceed letter and your IND number. Your drug product may have been produced months in advance, however, you cannot send it to the US for downstream processing. This review period does not need to be a waiting game. By shipping your material into our Canadian-based facility, we can perform your GMP packaging, labeling and/or kitting processes, complete QA processes, approve batch records and hold your finished goods until you get the green light to ship them into the US.

Why PCI Pharma Services?

At PCI, we are are focused on the needs of our customers and committed to supporting our clients with packaging solutions that truly differentiate, delivering flexible approaches and ensuring flexible and safe delivery of therapies with peace of mind.

Our Pre-IND speed solutions include:

Download our guide on Developing a Pre-IND Packing Strategy to Expedite Clinical Trial Timelines:

Please complete the form below download the guide, or to discuss your Pre-IND strategy with PCI’s expert team.

Spanning the cycle.A truly global proposition.

Always growing, we are driving development and connecting commercialization, and with 4300 people in 30 global GMP facilities, we are local and global