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
• Biologic license applications
• Investigational new drug applications
• Abbreviated new drug applications
• Marketing authorization 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.