Leverage our years of experience working with Health Canada to navigate and expedite your company’s Canadian regulatory affairs program. We believe that the success of a company is dependent on a well-conceived strategy coupled with a consolidated regulatory plan. We provide regulatory assessment, strategy, and guidance for the Canadian market, building scalable project models that meet your unique needs and budgets. Integrated solutions for Canadian regulatory requirements – Experts that will clarify and negotiate the regulatory path for Pharmaceuticals, Biologics, and Medical Devices. Our strategies include advice directly from the regulators that provide sponsors with clear direction on their development and clinical requirements. We have CMC Regulatory Compliance specialists who can prepare and file submissions effectively – Problem-solving to achieve and maintain compliance at any stage of the product lifecycle.

Regulatory Support

• CMC due diligence and gap analysis
• Pre-submission meetings
• Regulatory CMC dossier preparation and review
• Clinical Trial Application Consulting/IND submission to FDA
• Project Life Cycle Management
• Post-approval CMC support
• Registration of medical devices and medical Investigational Testing Authorization (ITA)