Commercial/Regulatory Support

Baxter's Regulatory Affairs Department is available to assist you with multiple types of applications. Our expertise can help avoid costly delays. We have experience with products evaluated by:

• The Center for Drug Evaluation and Research (CDER)
• The Center for Biologics Evaluation and Research (CBER)
• The Center for Devices and Radiological Health (CDRH)
• The Medicine Control Agency (MDA)
• The European Agency for the Evaluation of Medical Products (EMEA)
• The Canadian Health Protection Branch (HPB)

Our comprehensive menu of support services includes:

• Industry-leading regulatory support
• QA/QC
• New drug applications and updates
• Drug Master Files
• Site Master Files
• Biologic License preparation
• Investigational new drug applications

In addition, we provide regulatory support in the preparation of international filings in regions around the globe including Central and South America, Africa, Asia, Europe, and the Middle East.