Arora 297 Consultancy | Regulatory Affairs & Compliance

Secure Health Canada & FDA Approval
Without the Delays

Expert regulatory guidance for Medical Devices, NHPs, Foods, and Cosmetics. We navigate the complex compliance maze so you can focus on sales.

Over 1,000+ Successful Submissions • 20+ Years Experience

Trusted by over 100 Companies Across Canada & The USA

Sterasure Briotech Vivunt Euro Essentials

Regulatory Pathways We Manage

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Medical Devices

End-to-end support for Health Canada MDL/MDEL and US FDA 510(k) submissions. ISO 13485 audit readiness.

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Natural Health Products

NPN Product Licenses, Site Licensing, and GMP compliance. 90%+ success rate on submissions.

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US FDA Agent

Acting as your official US Agent for facility registration and communication with the FDA.

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Cosmetics

CNF notifications, label compliance reviews, and ingredient safety assessments for Canada & USA.

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Food & Supplements

CFIA/SFCR licensing, label reviews, and Nutrition Facts tables for compliant market entry.

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Biocides & Disinfectants

Regulatory support for hard-surface disinfectants, hand sanitizers, and biocidal products.

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20+ Years Experience
1,000+ NHPs Registered
100+ Device Licenses
98% Audit Success

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