Regulatory

In addition to complying with all relevant guidelines in our active and target markets, Polpharma Biologics provides regulatory CMC support to our clients around the world, leveraging more than 25 years of experience in the EU and US regulatory sectors through Polpharma Group.

 

 

Since our inception, we have applied an open, transparent approach to our interactions with global regulatory agencies, maintaining close contact throughout the entirety of the programs we support to ensure compliance from the start. We begin the dialogue as soon as a project enters our pipeline, thoroughly communicating what it is we are aiming to achieve, how we plan to achieve it and the scientific rationale behind our methodologies. This honest, science-driven approach provides regulatory authorities with the contextual knowledge to understand the evolution of your project and prevents costly delays at critical phases of development.