FDA CDER/CBER Electronic Labeling Guidance

The Center for Biologics and the Center for Drugs has issued a final guidance for the submission of labeling in electronic form for FDA review. (Note: it does not pertain to electronic labeling provided to users).

SoftwareCPR keywords: Blood Bank, electronic submission, online submission

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.