REGULATORY LAW
our EXPERTISE:
ThE cornerstone
of your success
Expertise in regulatory law concerning therapeutic products in Canada. With over two decades of experience, we guide healthcare companies through the intricate regulatory landscape, ensuring compliance with Health Canada’s, the PMPRB’s, Colleges of Pharmacists, and other regulatory bodies’ stringent requirements.
From clinical trials to marketing authorization, to access to information requests, to post-market surveillance & drug shortage reporting, we provide strategic legal advice that addresses every phase of the product lifecycle.
Our deep understanding of the regulatory framework, combined with a practical approach, helps clients navigate challenges and mitigate risks, enabling them to bring therapeutic products to market efficiently and with confidence.
Access to Information REQUESTS / public release of clinical information
Manufacturers choose Canadian Healthcare Law to safeguard their sensitive commercial, financial, and technical information in the custody of provincial governments and Health Canada. The firm assists in identifying and asserting applicable exemptions to disclosure, such as those protecting trade secrets and competitive information, and provides strategic counsel during the submission of confidential data to government bodies. Whether responding to access requests or preemptively structuring submissions to minimize risks, the firm ensures clients’ sensitive information remains protected while maintaining compliance with applicable transparency requirements..
Clinical Research
Legal review of all Clinical Research-related agreements, including Clinical Study/Clinical Trial Agreements (CSA/CTS), Sponsored Research Agreements, Patient Brochures, Informed Consent Forms (ICF), Investigator Agreements, Contract Research Organization (CRO) Agreements. Our productive working relationships with legal counterparts at sites and institutions expedites the legal review process.
Contract Manufacturing
Specialized legal services to support manufacturers in navigating the complexities of contract manufacturing agreements. Leveraging an extensive network of contract manufacturing sites, strategic counsel on drafting, negotiating, and managing manufacturing and supply agreements to ensure compliance with Canadian regulatory requirements and industry standards.
Advice on critical issues such as intellectual property protection, quality assurance obligations, liability allocation, and termination provisions. With expertise in the therapeutic products sector, helping clients secure reliable manufacturing partnerships that meet their production needs while mitigating risks and safeguarding their business interests.
Packaging & Labelling
There are three principal pieces of Federal legislation that regulate packaging and labeling of therapeutic products. The Food and Drugs Act has very specific guidelines for the labeling and packaging of all healthcare products. For the consumer healthcare market, the Consumer Packaging and Labelling Act also has important regulatory requirements. Also, the Competition Bureau, a federal agency, imposes standards of its own regarding net quantities for products' packaging and labeling. The firm advises manufacturers to comply with Canadian regulatory requirements for packaging & labelling of its products.
Pharmacovigilence
Comprehensive legal counsel on pharmacovigilance compliance, helping manufacturers of therapeutic products navigate their obligations under Canadian law. Services include advising on the establishment and operation of pharmacovigilance systems, drafting agreements with third-party service providers, and ensuring compliance with Health Canada’s Good Pharmacovigilance Practices (GVP) guidelines. Assistance with adverse event reporting requirements, risk management plans, and post-market surveillance obligations. Whether addressing regulatory inspections or developing policies to align with global pharmacovigilance standards, get practical solutions to help maintain patient safety, regulatory compliance, and reputational integrity in the healthcare industry.
Quality Assurance
Legal counsel on quality assurance matters to manufacturers of therapeutic products, ensuring compliance with Health Canada’s Good Manufacturing Practices (GMP) and other regulatory standards. Services include drafting and reviewing quality agreements, advising on inspection readiness, and addressing non-compliance findings. The firm helps clients establish robust quality systems, manage supplier relationships, and mitigate risks associated with product quality, ensuring safe and effective products reach the market while maintaining regulatory compliance.
Special Access Program
Expert legal counsel on Health Canada’s Special Access Program (SAP), which permits access to non-marketed therapeutic products for patients with serious or life-threatening conditions. Advice to manufacturers on navigating the regulatory requirements for SAP submissions, including eligibility criteria, physician requests, and product supply obligations. Services include drafting compliant agreements for the provision of SAP products, addressing liability and indemnity concerns, and ensuring adherence to Health Canada’s guidelines. With a deep understanding of this critical program, the firm helps clients support healthcare providers and patients while maintaining compliance with regulatory and ethical standards.