What We Offer

Regulatory services built around your outcomes.

Every engagement starts with your specific challenges — not a generic checklist. Here's how we help.

Who We Work With

Medical device manufacturers preparing for Health Canada submissions
Food producers pursuing BRC, SQF, or FSSC 22000 certification
Companies facing a regulatory inspection or audit
Organizations building or restructuring their QMS
Teams needing FSMA-compliant food safety plans
Cross-functional teams requiring regulatory training
Service 01

Strategic Planning

We develop tailored regulatory strategies for medical devices and food safety, guiding your organization from concept to market. Our team assists with certifications (BRC, SQF, FSSC 22000) and submission to health authorities.

What's Included

  • Developing regulatory strategies for medical devices and food safety plans (FSMA/HACCP)
  • Assisting organizations in achieving certifications: BRC, SQF, FSSC 22000, and more
  • Preparing and submitting applications to health authorities
  • Managing regulatory reports and ensuring ongoing compliance monitoring

Strategic Planning

Tailored to your regulatory environment and business stage.

Service 02

Internal Audits & QMS

Rigorous internal audits and Quality Management System support ensure your organization meets every applicable standard before a Health Canada inspection. We handle gap analysis and comprehensive documentation.

What's Included

  • Ensuring adherence to industry standards and regulatory requirements
  • Maintaining comprehensive regulatory documentation through robust Quality Management Systems (QMS)
  • Gap analysis against ISO 13485 and Health Canada MDR requirements

Internal Audits & QMS

Tailored to your regulatory environment and business stage.

Service 03

Operational Efficiency

We collaborate with your cross-functional teams to embed quality into everyday operations, lead regulatory projects, and build internal capacity through targeted training programs.

What's Included

  • Collaborating with cross-functional teams to uphold quality and safety standards
  • Leading projects within Regulatory and Quality departments
  • Training and capacity-building for internal teams

Operational Efficiency

Tailored to your regulatory environment and business stage.

Not sure which service fits your situation?

Let's talk it through. A 30-minute conversation is all it takes to get a clear picture of where you stand.

Schedule a Free Assessment