United Regulatory & Logistics

About United Regulatory & Logistics

Your trusted partner in FDA and Health Canada regulatory compliance since 2016.

Our Mission

To simplify the complex world of FDA and Health Canada regulatory compliance, enabling innovative health and wellness companies to bring safe, effective products to market efficiently.

Our Story

Founded in 2016 in South Florida, United Regulatory & Logistics has grown from a specialized medical device consultancy into a full-service regulatory firm serving manufacturers across medical devices, cosmetics, OTC drugs, and logistics. Based in South Florida, we serve clients worldwide.

Our Core Values

Integrity

We maintain the highest ethical standards in every regulatory interaction and client relationship.

Precision

Every submission, label review, and compliance assessment is executed with meticulous attention to detail.

Excellence

We pursue continuous improvement in our processes, staying ahead of evolving FDA and Health Canada requirements.

Partnership

We work as an extension of your team, invested in your success from initial strategy to post-market compliance.

Our Expertise

FDA 510(k) & De Novo Submissions
FDA Establishment Registration & Listing
Health Canada MDL & MDEL Applications
MoCRA Facility Registration & Product Listing
UDI System Implementation & GUDID
Quality Management Systems (ISO 13485/QMSR)
OTC Drug Monograph Compliance
cGMP Audits & Remediation
FDA Import/Export Compliance
Cosmetic & Drug Labeling Review

Ready to Navigate FDA & Health Canada Compliance?

Book a free 30-minute consultation to discuss your regulatory needs and get a custom roadmap.