From site quality to stability summaries and compliance to regulatory filings — we are here to help you through it all.
Regulatory & Quality
The regulatory landscape is ever-changing. Operate from a place of confident compliance with our expertise and robust resources and tools.
Compliance in Action
Our quest for a healthier world starts with our own internal practices. Our facilities meet all applicable global standards for quality systems and processes. Registered users can access all certification documents on our customer self-service portal, My Colorcon.
ISO 9001
Most Colorcon sites are ISO 9001 certified.
EXCiPACT
Most Colorcon excipient and packaging manufacturing sites are EXCiPACT certified.
IPEC
All Colorcon excipient manufacturing sites follow the principles laid out in the IPEC-PQG Joint Good Manufacturing Practices Guide For Pharmaceutical Excipients.
GMP
All Colorcon packaging manufacturing sites are certified to meet the ISO 15378:2017 GMP standards for primary packaging materials for medicinal products.
Access Answers Anytime
Register for My Colorcon, a user-friendly customer portal available 24/7 offering a robust suite of regulatory assessments, resources and tools for all registered users.
Explore Other Areas of Expertise
Your go-to-market goals benefit from a dedicated technical manager providing expertise across four additional specialties:
Stability
Optimized excipients, film coating and packaging protect against moisture, oxygen and light interaction, ensuring product consistency.
Product Authentication
Our on-dose digital authentication is the foremost in verification. Minimal cost per tablet and a mobile app round out reasons to turn to our team.
Tablet Design
Oral dosage design is art, science and our specialty. Our Quality by Design approach, rooted in 50+ years’ experience, yields stellar design across everything from differentiation to swallowability.
Patient Compliance
Reduce medication errors and improve patient adherence with our compliance-driven design.