Monitoring the global regulatory environment is a full-time responsibility in which Colorcon takes a leadership role. Customers look to our Global Regulatory Affairs Department for accurate and up-to-date information on the rapidly changing regulatory environment.
At Colorcon, we recognize the significant impact that current industry trends, new science and government regulations have on the global marketing of pharmaceutical products. Taking this into consideration during formulation will become even more important as companies utilize Quality by Design (QbD) concepts during development. Colorcon’s Global Regulatory Affairs Department employs experienced regulatory professionals around the world covering all major markets. Colorcon is an active member of the International Pharmaceutical Excipients Council (IPEC), the International Color Manufacturers Association (IACM) and various other trade associations. Colorcon’s regulatory professionals also participate on several compendial committees and working groups.
Global Regulatory Compliance
Colorcon customers can be assured that the raw materials chosen for use in all of our formulations are specified to either meet or exceed current domestic and/or international regulatory and compendial standards based on the intended applications and target markets identified by our customers.
Information Sheets with frequently requested information are available on the General Information Page. A section is also provided to provide quick answers to Frequently Asked Questions.
Colorcon is pleased to offer an on-line Request Page to provide our customers with an easy, direct way to request information or documents from our Global Regulatory Affairs and Quality Departments. This page has been designed in an interactive format that will allow us to provide you with the specific information you need more quickly. We can assure you that your request will receive our immediate attention.
