• |
Paper submission of Forms 2656, 2657, and 2658 are not accepted
by the FDA |
Affected
Life Sciences Manufacturers
|
|
| • |
SPL submissions must be filed via the FDA’s Electronic Submissions Gateway (ESG) |
• |
The HL7 Working Group is currently working on SPL Revision 5 which will include the submission of regulatory product information for Medical Devices |
Reed Tech Will Help You Comply with FDA SPL Regulations
|
• |
Provide easy-to-use data collection forms for your use or we will extract the necessary data directly from your source documents |
| • |
Accept all source formats (Word, PDF, etc.) |
| • |
Accurately transfer Labeler, Establishment, and Product Information into an SPL XML structure |
| • |
Check the presence and accuracy of data values |
| • |
Cross-check Labeler Code Request, Establishment Registration, and Product Listing/Labeling |
| • |
Perform in-depth validation that ensures that your SPL is FDA submission-ready |
| • |
Protect your data in our secure environment |
| • |
Make timely, dependable deliveries |
| • |
Submit your SPL via our Electronic Submissions Gateway (ESG) service |
•
|
Provide ongoing SPL Life Cycle Management |
|
Reed Tech's Partnered Services Solution |
 |
| Structured Product Labeling Samples |
 |
 |
 |
| |
| Reed Tech has the Experience You Need! |
• |
Successfully converted over 7,500 SPLs with high quality and accuracy |
• |
More than 300 life sciences clients, including more than half of the top ten global manufacturers of each of the following categories: Human Health, OTC, Biologics and Vaccines, and Animal Health |
• |
Excellent customer relationships and in-depth, up-to-date knowledge of FDA regulations |
• |
Over 40 years of providing high quality information management services to corporate and Federal customers |
|
Ben McGinty
Senior Director, Business Development
bmcginty@ReedTech.com
+1-215-441-6466
Reed Technology and Information Services
Inc.
7 Walnut Grove Drive
Horsham, PA
19044
U.S.A.
+1-215-441-6400
