We offer:
- Troubleshooting help with your submissions
- Comprehensive Services: Let Phoenix do it all for you!
- Introductory Webinars on E-Submissions and Drug Listing
Electronic establishment registration/product listing submissions for drugs are required by US FDA
as of June 1, 2009.
Incorrect submissions can potentially cost your company millions of dollars in lost time. Phoenix can help you with problems that are encountered when making electronic submissions. You chose the type and amount of assistance you need.
Troubleshooting Your Electronic Submissions
Phoenix offers one-on-one consulting assistance with our experienced
compliance expert, David Clark. Call him 9-5 Central time, Monday-Friday, for help resolving issues/errors with electronic submissions forms that you're having trouble completing, validating, or sending. Don't waste your precious time trying to interpret
FDA's procedures on resolving technical errors relating to
submission files. Our consultant understands error terminology and
recognizes the errors returned by the validation step. For example, send
your submission file (complete with errors) to our compliance expert and he
will correct the errors, validate the file, and return it to you ready to
submit to FDA. He has resolved errors for many other companies in just a
short time.let him help you be more efficient. Contact us for details.
Comprehensive Services: Let Phoenix do it ALL for You
Phoenix can complete the electronic submission forms for you and then validate and submit them if you decide that this approach would be more cost-effective. Alternatively, don't concern yourself with obtaining a WebTrader account.send your competed, validated forms to Phoenix and we will submit them to the FDA Electronic Submissions Gateway using our approved WebTrader account. We will send you email confirmation from FDA that the Agency has received and accepted the files. Contact us for additional information.
Introductory Webinars on E-Submissions and Drug Listing
If you have not yet obtained a WebTrader account with the FDA Electronic Submissions Gateway, you should be aware that this is a time-consuming and frustrating process. Pharmaceutical companies across the US are exhausting countless hours attempting to become a "trading partner" with FDA. Let our compliance expert explain the basics for obtaining this account and walk you through the process for downloading and completing pre-formatted submission forms and sending the final submissions. Phoenix offers this training in 2 informative webinars.
Who Should Attend:
QA and Regulatory Staff and Managers and others who must download, complete, validate, and submit the drug establishment registration and drug listing documents electronically to FDA.
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