Global Regulatory Support Services

Product Details

Navigating the regulatory environment can be complex. To assist you, BioPharma Solutions brings a comprehensive portfolio of regulatory support services as part of our sterile contract manufacturing solutions to help you with your regulatory filings, including:

New drug applications and updates
Biologic license preparation
Investigational new drug applications
Drug Master Files
Site Master Files
Drug listings

Helping our partners with the regulatory filing process, our expertise can be used to support the execution of your regulatory strategy and in the preparation of regulatory submissions around the globe.