This page explains our new FDA eCopy Service where we print and ship your FDA eCopy submission so you can avoid the hassle.
eCopy Service – We feel your pain
Formatting flash drives takes forever. Driving to Staples to deliver a flash drive to print a hardcopy is never convenient–when they are open. Your hands turn red and blister from punching holes in 1,000 pages–especially twenty pages at a time. You scream when you realize that 500 pages will fit in my 3-ring binder, but Staples used thicker paper so you can only manage 350 pages per binder. You get so frustrated when you rush to meet the cut-off time for shipments and you miss it by 5 minutes. Most of all, you get really mad when you get an email from the FDA that my FDA eCopy failed to upload.
eCopy Service – The solution
To avoid this pain you need a box full of pre-formatted flash drives, a high-speed printer that automatically punches holes for 3-ring binders, reams of 20# paper (and no other weight), a case of 3-ring binders of every size, a FedEx shipping location down the street and the eCopy validation software loaded on your computer to ensure every file name is perfect.
eCopy Service – Our capabilities
On Tuesday, October 25 a high-speed (50+ ppm) printer was installed. Now we can print a 1,000-page FDA submission in 20 minutes. We have the eCopy validation software loaded on all our computers. All the flash drives are pre-formatted. We have every size of 3-ring binder from 1″ to 5″. FedEx stops by every day between 4:00pm and 5:00pm to pick-up express shipments for the FDA. If we need a later cut-off time, the FedEx shipping location is only 4.4 miles (7.1 km) away and the truck does not leave until 6:25pm. There’s also zero traffic in rural Vermont.
3 Steps for You
- Share a link with us for your submission in Dropbox that is ready to print.
- Make sure you include color printing instructions in Dropbox if you want color printing.
- Pay the Paypal invoice we send you to confirm your order is ready to print.
5 Steps for Us
- We copy your files from Dropbox onto a flash drive.
- We validate the eCopy using software provided by the FDA.
- If eCopy fails internally, we notify you of the problem and recommend solutions.
- If eCopy passes internally, we send you a Paypal invoice.
- After we receive payment, we print your submission and place it in a binder.
- We pack the binder and the flash drive for shipment.
- We create a FedEx shipping label and send you the tracking number.
How long does eCopy Service take?
- Creating an eCopy flash drive takes about 1 minute.
- Validation of the eCopy takes seconds, but sending a Paypal invoice takes another minute.
- Printing your submission takes less than 30 minutes.
- Packing your shipment takes about 3 minutes.
- Creating a FedEx shipping label takes about 2 minutes.
The entire eCopy Service takes less than 45 minutes.
FDA eCopy Checklist
Subscribe to download our checklist.