Clinical Trials

Regulatory Affairs CMC guidance documents to help prepare INDs

At the very first time, if any company is planning to apply for an IND and start planning internally, it starts with the a basic target...

Jeremy Jakob

Jul 20, 20234 min read

CMC, or Chemistry, Manufacturing and Control are activities needed to ensure overall pharmaceutical product quality.

Jeremy Jakob

Mar 29, 20234 min read

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

Jeremy Jakob

Mar 8, 20235 min read