Health Canada & FDA Approval, Without the Delays
Hands-on regulatory consulting for medical devices, natural health products, cosmetics, foods, and OTC products—delivered by experienced experts, not layered account teams.
1,000+ Successful Submissions • 20+ Years of Regulatory Experience
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, cosmetics, food, OTC products, and biocides.
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.
Learn more →Natural Health Products
NHP licence applications, site licensing, and GMP compliance support for Health Canada submission readiness.
Learn more →US FDA Agent
U.S. FDA Agent representation for facility registration, product listing, and regulatory communications.
Learn more →Cosmetics
Cosmetic notification, label review, and ingredient compliance support for Canada and U.S. market access.
Learn more →Food and Supplements
Food regulatory support for CFIA, SFCR, labeling, and import compliance across Canada.
Learn more →Biocides and Disinfectants
Classification, submission strategy, labeling, and Health Canada compliance support for disinfectants and biocidal products.
Learn more →Engage Senior-Led Regulatory Guidance
Supporting Health Canada and FDA compliance planning for regulated products, with focused direction for submission readiness, audit alignment, and market-entry progression.
Schedule a Regulatory Assessment