Health Canada & FDA Approval, Without the Delays
Hands-on regulatory consulting for medical devices, natural health products, and conventional foods—delivered by experienced experts, not layered account teams.
1,000+ Successful Submissions • 20+ Years of Regulatory Experience
Trusted by companies across Canada and the United States.
Why Choose Arora 297 Consultancy
Delivering senior-led Health Canada and FDA regulatory support, reducing delay exposure, and strengthening submission readiness across medical devices, natural health products, and conventional food frameworks.
Senior-Led Oversight
Engagements are directed by experienced regulatory leadership rather than layered account management structures.
Cross-Border Regulatory Coverage
Health Canada compliance and FDA support are managed within one coordinated consulting framework.
Practical Submission Execution
Classification, licensing, labeling, documentation, and audit readiness are addressed with execution-focused discipline.
Focused, High-Touch Support
A boutique consulting model enables direct guidance, tighter alignment, and stronger responsiveness than larger firms.
Regulatory Services: Health Canada and FDA Support
Senior-led regulatory consulting for organizations requiring structured Health Canada compliance, FDA support, and market-entry planning across regulated product categories.
Medical Devices
Health Canada MDL and MDEL support, FDA 510(k) readiness, and audit preparation for compliant device market entry.
Natural Health Products
NHP licence applications, site licensing, and GMP compliance support for Health Canada submission readiness.
US FDA Agent
U.S. FDA Agent representation for facility registration, product listing, and regulatory communications.
Food and Supplements
Food regulatory support for CFIA, SFCR, labeling, and import compliance across Canada.
Biocides and Disinfectants
Classification, submission strategy, labeling, and Health Canada compliance support for disinfectants and biocidal products.
Ready to Get Your Product Approved?
Stop dealing with regulatory delays. Let our senior-led team streamline your Health Canada compliance and FDA submissions for a seamless market entry.
Schedule Your Assessment Now