Articles

FDA E-Submission

As we enter 2017, we want to remind all our clients that the FDA is requiring their e-submission system be used for most communication with them. Kinexum has extended its capabilities for clients and now offers a complete submission process from the development and authoring of submissions to the final submission through the FDA’s electronic gateway.

 

Kinexum continues to offer the highest level of regulatory document preparation based on each client’s specific regulatory strategy.  Our submission development teams often are supplemented with highly experienced regulatory, CMC, pre-clinical, clinical consultants as well as medical writers to ensure a clear narrative and succinct presentation of the data. Our goals are to deliver the highest quality submission possible. Want to learn more about Kinexums submission capabilities? contact Steve Casey at This email address is being protected from spambots. You need JavaScript enabled to view it. '; document.write(''); document.write(addy_text69081); document.write('<\/a>'); //-->\n This email address is being protected from spambots. You need JavaScript enabled to view it. .