WELCOME
BioNex Solutions is a regulatory consulting firm focused exclusively on the natural health products and dietary supplement sectors.
We help health product brands, manufacturers, and innovators successfully launch and maintain regulatory-compliant products in Canada and the U.S.
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MISSION
“To simplify compliance and enable growth for natural health and wellness companies through trusted regulatory support.”
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OUR EXPERTISE
- Natural Health Product Regulations (Canada – NNHPD)
- Dietary Supplement Regulations (U.S. FDA 21 CFR 111)
- Site licensing support (for foreign site recognition)
- Ingredient classification and monograph alignment
- English-French bilingual label review
Why Work With Us?
5+ years of regulatory consulting experience
Proven success with NPN filings and product launches
Strong understanding of both Canadian and U.S. regulatory systems
Expert-led label compliance and ingredient reviews
Transparent processes and fast response times
WHAT WE DO
WHAT WE DO
Regulatory Consulting
We help you navigate Health Canada, FDA, and global compliance frameworks to bring natural health products to market safely and legally.
Product Licensing
From NPN applications to label reviews and site reference submissions — we manage your entire compliance process with precision.
Cross-Border Trade
We provide strategic guidance and documentation support to streamline import/export of NHPs and supplements between markets.