Regulatory Affairs — Q Nutritions

Global Compliance & Licensing Support

Regulatory Affairs

Navigate complex supplement regulations with confidence. Our regulatory affairs team provides expert guidance for Health Canada NHP licensing, FDA compliance, and international market approvals.

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Overview

Regulatory Affairs at Q Nutritions

Regulatory compliance is one of the most complex challenges in the supplement industry. Q Nutritions' regulatory affairs team has successfully guided hundreds of products through Health Canada, FDA, and international regulatory processes. We stay current with evolving regulations so your products remain compliant in every market.

Health Canada Natural Health Product (NHP) license applications
US FDA dietary supplement notification and registration
EU Novel Food and food supplement compliance
Product license number (NPN/DIN-HM) applications
Label claim substantiation and health claim review
Adverse event reporting and post-market surveillance
Import/export regulatory documentation
Ongoing compliance monitoring and regulatory updates

Health Canada NHP

Complete NHP product license applications, site license support, and compliance management.

FDA Compliance

FDA dietary supplement registration, DSHEA compliance, and 21 CFR Part 111 GMP guidance.

EU Regulations

EU food supplement directive compliance, Novel Food applications, and EFSA health claims.

Label Review

Comprehensive label review for claims, supplement facts, warnings, and market-specific requirements.

International Markets

Regulatory guidance for Australia (TGA), UK, Middle East, Asia-Pacific, and other markets.

Compliance Monitoring

Ongoing regulatory monitoring and proactive compliance updates as regulations evolve.

Why Choose Us

Key Benefits

Team of regulatory specialists with 20+ years combined experience

Successful track record with 500+ product license applications

Health Canada and FDA regulatory expertise under one roof

Proactive monitoring of regulatory changes in all major markets

Faster approval timelines through established regulatory relationships

Complete documentation management and submission tracking

Label claim substantiation with scientific literature support

Post-market compliance monitoring and adverse event support

Cost-effective regulatory strategy to minimize approval timelines

Our Approach

How We Deliver

Regulatory Assessment

We assess your product and target markets to determine regulatory pathway and requirements.

Documentation Preparation

Complete regulatory dossier prepared including formulation, safety, and efficacy data.

Submission & Liaison

Application submitted with ongoing liaison with regulatory authorities.

Approval & Maintenance

License obtained and ongoing compliance monitoring maintained.

Questions

Frequently Asked Questions

How long does Health Canada NHP licensing take?

Health Canada NHP product license applications typically take 60-180 days depending on product category and completeness of submission. We optimize submissions to minimize review time.

Do I need FDA approval to sell supplements in the US?

Dietary supplements in the US are regulated under DSHEA and do not require pre-market FDA approval. However, FDA registration, GMP compliance, and proper labeling are required. We ensure full DSHEA compliance.

Can you help with international market entry?

Yes. We provide regulatory guidance for 20+ countries including EU, UK, Australia, UAE, India, and Southeast Asia. Each market has unique requirements that our team navigates for you.

What if my product gets rejected?

Rejections are rare with our thorough pre-submission review process. If a deficiency notice is received, we respond promptly with additional data and documentation to resolve the issue.

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Ready to Get Started?

Contact our team today for a free consultation on your regulatory affairs needs.