Hello,
I am preparing a CTA for a Mixed Urinary Incontinence Phase II trial for women above age 18 years. Our manufacturer is located in Belgium.
While reading through the guidelines I came across the requirement of DMF to be filed prior to CTA.
We were planning to submit the CTA in the first week of January and do not have the DMF submitted. Is it required for all CTA applications. Any suggestions on how to move forward?
Thank you
Nikita Kathpal, MS
Regulatory Officer II, USA & Canada
Pharm-Olam International
450 N. Sam Houston Parkway, E. Suite 250
Houston, TX 77060
Email: nikita.kathpal@pharm-olam.com
Direct line: +1 713-559-7964