Leverage the Canadian market expertise of a proven industry leader.
Optum™ Canadian Regulatory Affairs and Quality Assurance
The Optum team of dedicated, experienced consultants can give you the support you need to simplify and expedite the Canadian regulatory process throughout the entire product lifecycle. Our project experience includes pharmaceuticals, biologics, medical devices, NHPs, cosmetics and foods.
Questions we can help you answer:
- Can we adapt our FDA or EMA dossier for submission to Health Canada?
- What do we need to do to establish a Canadian affiliate of our pharmaceutical business?
- Do we need a Canadian agent to add a Canadian site to our clinical study?
- When do I require an establishment license?
- What are the pharmacovigilance requirements in Canada?