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BioPharma Solutions BioPharma Solutions
Sterile Contract Manufacturing

Global Regulatory Support


Our thorough approach to compliance.

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.

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