News

September 2020
Real CMC Tips and Insights

published 6 Oct 2020

Since the beginning of July 2020, we have published weekly CMC tips and insights from our CMC experts on our Real CMC LinkedIn page, as a service to our followers. The tips we published in September 2020 are collected here, for convenience. Make sure you follow Real CMC and Real Regulatory Ltd for regulatory news, reports and hints.

SOPs in the Dossier

 

Reporting Impurities

 

Dissolution Profiling of Biobatches

 

Specifications in the Dossier

 

Polymorphism