Case Study: a large pharmaceutical company lifts clinical hold with Certara’s CMC writing support

CMC Writing Support Helps Client Lift Clinical Hold

A large pharmaceutical company faced a significant regulatory challenge after receiving a nearly two-year clinical hold from the FDA. The client needed to rewrite and update 96 complex CMC documents for a drug-device combination to support their IND resubmission, but they only had 1.5 months to complete this critical task. They engaged Certara for its regulatory writing services to address this urgent need.

Certara assigned a senior regulatory writer to lead the project and assembled a support team to work on the extensive documentation. The vendor provided submission leadership and expert support, with its Document Quality team working around the clock to perform quality control and meet the aggressive deadline. As a result, the client was able to resubmit the IND on time, and the FDA lifted the clinical hold within one month of submission.