Regulatory Copying & Printing
Four Point Printing have specialised in producing Regulatory Dossiers since 1979 and have always produced the very highest quality possible with the best technology available. We fully understand the need for high quality, speed and accuracy necessary for regulatory work and aim to help keep the assessor happy with your submission. We are happy to help with all of your printing needs, from one copy of a small volume or updated section to a large submission, Four Point always provides a quick and accurate service from multiples to very small quantities such as your own single archive copy.
Common Technical Document - CTD
We have produced many CTD's since early 2003 and are very familiar with the CTD process. We have our own copy of the EMEA guide to producing a Common Technical Document, and refer to it as well! Having produced many CTD's we have evolved our own highly efficient, successful way of producing tabs, with or without supplied files, frequently from supplied Table of Contents.
Mutual Recognition
We have produced MRP's and centralised procedures, shipping to all countries on the same day as expected. We know Responses need to be produced very quickly and accurately and work with you to meet that deadline
Scanning
When scanning legacy documents we always produce one copy and check 100% for any errors. We liaise with you for original queries, which means we find things previously missed and corrections can still be made at this point. We then correct, add or amend and produce further copies. We can take your work in stages if this helps you. Electronic storage is also available from the scanned pages and we currently can supply files via email or on CD, DVD, FTP server, DAT, Travan and DLT tape.
File Handling
We can take your files from Word, Acrobat pdf, docuBridge and add tabs. We can take files direct from EZsubs and Core Dossier and print direct. We have fast internet so any last minute changes can be emailed to us. We also have our own FTP server to receive your files securely and directly into our system
Amendments and Changes
If you would you like pagination or headers and footers added we can add these in for you, for the whole dossier or just the volumes that require it. Changes, additions and corrections can be made at any time.
Production
Our main method of production allows us to print 135 copies a minute, up to 3 million copies per month and store work on file for future work.
Quality
Quality is always to high standards. When we check copy and originals we often pick up original queries missed by Regulatory experts as we look at the work from the print perspective and ask questions like "Are all the pages in a report and in the right order ?"
Deadlines
Agreed deadlines are met or beaten
Binding
Covers and spines for ring binders can be produced and inserted as black and white or colour prints. We stock ring binders in 15mm, 25mm, 40mm, 50mm and 65mm capacities as well as lever arch files and also bind in many other ways if required.
Staff
The usual attention to detail and dedication of our whole team is always included at all stages. We will live and breathe your project and advise and help as much as we can.
Premises
You are welcome to visit our premises at any time. We easily accommodate large dossiers in our modern unit with 1 x 3 metre tables. Your work would have a designated area. Customers usually visit us to see their work here as this is far easier than having it back in their offices where there is usually limited space, saving time effort and money. Our factory is large, 6000 square feet footprint, plus mezzanine and we create 'Chinese walls' and divide the area when we have more than one project in house. Our premises are at your disposal during your project and we encourage you to visit us at any stage of the process subject, of course to any areas with other pharmaceutical work being out-of-bounds, as you would expect. Clients can remain on site during their entire project.
Facilities
Offices, pcs, printers and benches are available whenever necessary. Pallet racking is available for storage and call off.
Collection, Shipping and Delivery
We can collect and deliver originals and copies.
We ship direct to UK agencies, or overseas discounting on FedEx prices in our own design export boxes.
We handle all administration, paperwork, packing, shipping and proof of delivery.
Four Point Regulatory Menu
Choose individual or all the processes from the menu we offer to the Regulatory professional:
Our experience covers the most effective way of producing submissions quickly, correctly and to a sensible price level. Most importantly our people have very high quality standards and we always, somehow, manage to do what may appear to be the impossible. Small Printing only work is welcomed as well as the larger projects and work can stop and start as your needs demand
We have over twenty years experience in Regulatory Printing and we promise
Contact us about Regulatory Printing