This page explains our new FDA eCopy Service where we print and ship your FDA eCopy submission so you can avoid the hassle.

FDA eCopy Binder

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.

eCopy Service

3 Steps for You

  1. Share a link with us for your submission in Dropbox that is ready to print.
  2. Make sure you include color printing instructions in Dropbox if you want color printing.
  3. Pay the Paypal invoice we send you to confirm your order is ready to print.

5 Steps for Us

  1. We copy your files from Dropbox onto a flash drive.
  2. 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.
  3. After we receive payment, we print your submission and place it in a binder.
  4. We pack the binder and the flash drive for shipment.
  5. We create a FedEx shipping label and send you the tracking number.

FDA eCopy

How long does eCopy Service take?

  1. Creating an eCopy flash drive takes about 1 minute.
  2. Validation of the eCopy takes seconds, but sending a Paypal invoice takes another minute.
  3. Printing your submission takes less than 30 minutes.
  4. Packing your shipment takes about 3 minutes.
  5. Creating a FedEx shipping label takes about 2 minutes.

The entire eCopy Service takes less than 45 minutes.

FDA eCopy Checklist

Fda ecopy checklist 161103

Subscribe to download our checklist.

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