20+
Years Experience
1,500+
SKUs Reviewed
1,000+
NHP Submissions
100+
Active Clients
100+
MDLs Licensed
Zero
Critical Failures
Industries We Empower
Strategic guidance tailored to specific product classifications.
Medical Devices
Supporting Class I-IV devices with a focus on market entry speed and safety.
- Health Canada MDEL & MDL
- FDA 510(k) Strategy
- ISO 13485 QMS Readiness
- Post-Market Vigilance
Natural Health (NHPs)
Navigating the LNHPD with precision and ingredient defensibility.
- Product Licensing (NPN)
- Site Licensing & GMP Review
- French/English Labeling
- Health Claim Substantiation
Food & Cosmetics
Cross-border compliance for highly competitive retail categories.
- CFIA / SFCR Compliance
- Cosmetic Notification Files
- OTC Drug Facts Labeling
- US-Canada Gap Analysis
Client identities are kept confidential. Anonymized case summaries can be shared during a strategy call.
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