Chemistry/Manufacturing/Controls, Drug Master File Dossiers, Electronic Submissions Preparation, GMP Compliance, Medical Devices/Combination Products, Medical Information, Pharmacovigilance, Regulatory Affairs/Regulatory Strategy, Regulatory Document Preparation, Rx to OTC Switch
GLOBAL REGULATORY CONSULTING:
Across Disciplines. Through the Lifecycle. Around the World.
CANREG (now Optum) is a consulting firm dedicated exclusively to regulatory affairs consulting for the pharmaceutical, biotechnology and medical device industries. More than 100 in-house consultants and staff support our clients around the world. Optum has successfully negotiated drug and medical device approvals in more than 60 countries. Our senior consultants have over 30 years experience dealing with the Food and Drug Administration (FDA), Health Canada, and European regulatory agencies.
Wherever the product is in the development process or post-marketing stage, Optum can help navigate the path forward. Global regulatory agencies continually revise guidance documents, requirement and regulations. Optum clients benefit from working with a partner actively involved with these changes every day. For many clients, this translates into shortened time-to-clinic and ultimately, time-to-market.
Optum provides global regulatory services for drugs, biologics, medical devices, natural health products, food, Over-The-Counter (OTCs), and cosmetics, including:
• Global Marketing authorizations (NDA, NDS, MAA)
• Clinical trial authorizations (IND, CTA)
• QA Services/GMP auditing
• Regulatory assessment and strategy development
• eCTD Services and Regulatory Publishing
• Pharmacovigilance and Medical Information Support
• Medical writing
Our 22,000 square foot building in Dundas, Ontario has been designed for the efficient development of regulatory submissions. Optum also has offices in Quebec, New Jersey and Ireland. We have a Regulatory Operations Department that is responsible for electronic and paper publishing of all submissions. A Quality Assurance Department reviews all work before it is released.
www.optuminsight.com/canreg or 1 (866) 722-6734