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 “May Proceed” Letter from the US FDA?
Utilizing PCI Clinical Trial Services’ Pre-IND Speed to Study™ service 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 approval and IND number.
How you ask?
Once you have filed for your IND with the FDA, it can take up to 30 calendar days to receive FDA approval 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 time 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, sign off on your batch records and hold your finished goods until you get the green light to ship them into the US.
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 to Study offerings include:
We provide scalable and comprehensive Primary and Secondary packaging solutions for all phases of the clinical lifecycle.
Our primary packaging capabilities for solid dosage forms include:
- Over encapsulation support for blinding
Our secondary and other packaging solutions for all dosage forms, at any temperature, consist of:
- Labels & Overlabeling (single panel to booklet)
- Kits /Cartons
- Wallets or pouches for blisters
- Retest date extension/shelf-life extension
- Just-in-time labeling at time of distribution
- Device assembly
- Child resistant and compliance prompting packaging
Our experienced team will work with your team to design a clinical label that not only fits your unique packaging requirements, even with specific temperature constraints, but they can assist to help meet the regulatory requirements of the countries involved in your clinical trial. Utilizing our fully validated in-house printing system, this site is capable of printing open labels, blinded or double-blind labels, single or multi-panel labels, including multi-language texts.
Our highly skilled project management team are experts in the Clinical Trial supply chain process and will work with you to design a kit design that is custom to your product and needs.
We have significant global expertise with multiple temperature-controlled packaging, storage and distribution solutions available to fit your unique needs – these include:
- Ultra Low (-80°C to -60°C)
- Frozen (-15 to -25°C)
- Refrigerated (2°C – 8°C)
- Controlled room temperature (15-25°C)
Our GMP-compliant storage capacity and global distribution capabilities enable us to fulfil your unique needs, no matter the size or scope of your project. We can facilitate same day or next day shipping for any location within Canada. Crossing the border into the US is seamless due to our proven traffic lane transport process and broker clearance, allowing for overnight shipment from Canada to anywhere in the Midwest and East Coast.
We can also manage all your logistics in a sustainable way through our interface-friendly shipping container programme – Credo CubeTM