Sierra Labs Blog

By: Sierra Labs on 7/29/20 9:12

Uncovering how Agile practices fulfill Software as a Medical Device (SaMD) Development

By: Sierra Labs on 7/16/20 12:57

Unpacking the FDA guidelines and regulations under 21 CFR Part 820.

By: Sierra Labs on 5/21/20 11:10

How strategic labeling can improve regulatory compliance and operational efficiency

By: Sierra Labs on 5/14/20 11:38

Unpacking the 4 stages of a Clinical Development Program.

By: Sierra Labs on 2/12/20 10:58

A simple guide to conquering your Pre-Submission Meeting with FDA, plus some free tools!

By: Sierra Labs on 1/21/20 15:28

A simple breakdown of 20 conferences you don't want to miss this year.

By: Sierra Labs on 1/14/20 13:10

A comprehensive table of CBER's 20 new biological approvals and their corresponding approval dates, intended uses, and companies.

By: Sierra Labs on 1/10/20 12:45

A comprehensive table of the 48 new drug approvals and their corresponding active ingredients, diseases, estimated sales, and companies.

By: Sierra Labs on 12/23/19 11:12

Learn how to achieve GxP Cloud Compliance and simplify your Cloud Validation process with 1 simple trick.

By: Sierra Labs on 11/26/19 17:38

Here's how to conquer Cloud compliance in the regulated industry.