IND-Enabling Studies: Critical Steps Biotech Firms Must Master Before FDA Submission
For biotech companies aiming to initiate human clinical trials, filing an Investigational New Drug (IND) application is a pivotal milestone. […]
CMC strategy
Why CMC Readiness is Essential for Successful Product Launches in the Pharmaceutical Industry
As the pharmaceutical industry evolves, the complexity of molecules, the emergence of biosimilars, and expedited regulatory pathways are pushing the