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Regulatory and Quality Support

Avoid Regulatory Risk and Ensure the Right Excipient Selection

The impact of industry trends and regulations on the development and manufacture of pharmaceutical and food/dietary supplement products may cause costly delays in bringing products to market. The need for clear, up-to-date, regulatory guidance is more important than ever.


At Colorcon, we provide outstanding regulatory and quality support that is unmatched by any other film coating or excipient supplier. We help our customers minimize risks by offering:

  • Advice on regulatory requirements for target markets 
  • Assurance that product components and Colorcon coating and excipient products meet appropriate regional regulatory requirements
  • Quality by Design (QbD) information


This is achieved by:


  • Maintenance of regulatory reference databases
  • Preparation and maintenance of petitions, licenses, and Drug Master Files (DMF) to ensure appropriate regulatory status for intended use in target markets
  • Monitoring and participation in key industry groups


Expect the Exceptional, tailored to your needs.  Visit the My Colorcon section of our website and join the thousands of users benefiting from the value of direct access to Colorcon's regulatory support!