Substance Law provides legal and consulting services to businesses and individuals dealing with Health Canada. We advise clients on audits, inspections, warning letters, notices of non-compliance, fines, and broader regulatory obligations under Canadian federal law, including under the Cannabis Act, Food and Drugs Act, and the Controlled Drugs and Substances Act.
Health Canada matters are often time-sensitive and high-risk. Our lawyers help clients respond strategically, manage enforcement risk, and achieve compliance while protecting their business interests.
Health Canada Legal & Regulatory Services
Responding to Health Canada Audits & Inspections
We assist clients before, during, and after Health Canada audits and inspections, including:
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Audit and inspection readiness assessments
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Review of policies, procedures, and documentation
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Legal representation during inspections
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Strategic responses to inspection findings
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Corrective action planning and follow-up
Early legal involvement can significantly affect outcomes and reduce enforcement exposure.
Health Canada Warning Letters & Compliance Notices
If you receive a warning letter, notice, or compliance communication from Health Canada, we assist with:
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Reviewing and assessing the allegations
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Preparing formal written responses
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Managing deadlines and regulator expectations
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Developing corrective and preventive actions
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Acting as counsel and point of contact with Health Canada
Clear, well-structured responses are critical to limiting further enforcement.
Notices of Violation, Penalties & Fines
We advise clients facing administrative or monetary enforcement action, including:
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Notices of violation
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Administrative monetary penalties (AMPs)
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Compliance orders and enforcement actions
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Risk assessment and enforcement strategy
We help clients understand their options and respond in a way that protects long-term business viability.
Regulatory Compliance & Advisory Services
We provide proactive compliance advice to help clients meet ongoing Health Canada obligations, including:
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Regulatory compliance assessments
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Risk management and compliance strategy
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Internal compliance program development
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Ongoing advisory support
Proactive compliance reduces the likelihood of audits, penalties, and business disruption.
Product & Regulatory Strategy
We advise on regulatory considerations that affect product development and market entry, including:
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Regulatory classification and compliance strategy
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Advertising and promotional compliance
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Risk assessment for novel or innovative products
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Regulatory due diligence for transactions
Our advice is practical and aligned with Health Canada’s enforcement approach.
Enforcement Risk Management & Remediation
When issues arise, we assist with:
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Internal investigations and root-cause analysis
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Corrective and preventive action plans
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Regulator communications and negotiations
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Ongoing monitoring and remediation
Our goal is to resolve issues efficiently while minimizing reputational and financial risk.
Industries & Clients We Assist
We advise a broad range of clients dealing with Health Canada matters, including:
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Manufacturers and distributors
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Importers and exporters
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Retailers and service providers
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Startups and established companies
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Individuals subject to regulatory action
Why Choose Substance Law as Your Health Canada Lawyer?
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Experience with Health Canada audits, enforcement, and compliance
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Strategic, regulator-aware legal advice
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Clear communication and practical guidance
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Focus on risk management and business continuity
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Toronto-based firm serving clients across Canada
Work With a Health Canada Lawyer & Consultant
If you are facing a Health Canada audit, warning letter, notice, or fine—or want proactive compliance support—Substance Law provides experienced legal and regulatory guidance.
Contact us today to speak with a Health Canada Lawyer & Consultant.
Frequently Asked Questions About Health Canada Lawyers in Canada
What does a Health Canada lawyer do?
A Health Canada lawyer assists businesses and individuals with audits, inspections, warning letters, notices of non-compliance, fines, and regulatory enforcement matters. This includes advising on compliance obligations, responding to regulators, and managing enforcement risk under Canadian federal law.
When should I hire a Health Canada lawyer?
You should hire a Health Canada lawyer if you receive a warning letter, audit notice, inspection request, notice of violation, fine, or other regulatory communication from Health Canada. Early legal advice can significantly affect the outcome and reduce enforcement risk.
What is a Health Canada warning letter?
A Health Canada warning letter is a formal notice indicating that the regulator believes there may be non-compliance with federal health-related laws or regulations. These letters often require a written response and corrective action within strict deadlines.
Can a lawyer help respond to Health Canada audits or inspections?
Yes. A Health Canada lawyer can help prepare for audits or inspections, advise during regulator interactions, review inspection findings, and develop corrective and preventive action plans to address compliance concerns.
What happens if I receive a notice of violation or fine from Health Canada?
If you receive a notice of violation or fine, a lawyer can assess the allegations, explain your response options, manage deadlines, and advise on payment, representations, or dispute strategies depending on the circumstances.
Can a Health Canada lawyer communicate with the regulator on my behalf?
Yes. A Health Canada lawyer can act as your representative and primary point of contact, responding to letters, information requests, and enforcement communications in a clear and strategic manner.
Do Health Canada issues affect business transactions?
Yes. Health Canada compliance and enforcement issues can affect business sales, acquisitions, and investments. Legal advice is often required for regulatory due diligence and risk assessment in transactions.
Can a lawyer help prevent Health Canada enforcement action?
Yes. Proactive legal advice on compliance, internal audits, and regulatory strategy can help reduce the risk of Health Canada audits, warning letters, and enforcement actions.
How much does a Health Canada lawyer cost?
The cost depends on the complexity of the matter, such as audits, enforcement proceedings, or advisory work. Many matters are handled on an hourly or flat-fee basis, with estimates are typically provided after an initial review.
Do you work with businesses or individuals?
Health Canada lawyers work with both businesses and individuals, including manufacturers, distributors, importers, retailers, and individuals subject to regulatory action.
