Monitoring the global regulatory environment to assure that our products meet or exceed domestic and/or international compendia standards is a serious responsibility. We recognize the significant impact that current industry trends, new science and rapidly changing government regulations have on the global marketing and manufacturing of excipients.
Colorcon's Regulatory Affairs and Quality Departments work closely together to stay up-to-date on all regulatory changes that affect the components used in formulating our products. Their role of providing accurate information and tracking new developments ensures our products meet the compendia requirements and the highest standards for quality, safety and functionality. Our Global Regulatory Affairs group can also guide you in selecting the right Colorcon product to meet your application and target market.
Frequently Requested Compliance Information
Regulatory & Quality documents for our product registrations, colorant regulations and more are available on our General Information Page.
To further support our customers, we maintain a Frequently Asked Question Section.
In addition, our on-line Request System provides customers with an easy, direct way to access information and track the delivery of other documents from our Regulatory Affairs and Quality Departments.
Pharmaceutical Industry Activity
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.
