Regulatory

Our Regulatory Group is proud to be able to assist clients with government approvals anywhere across Canada.

Initiating a new project or undertaking product research and development takes innovative thinking. Obtaining critical government approvals – particularly in any heavily regulated industry – requires the guidance of experts in the field.

The internationally recognized Regulatory Group at Cassels is ready to guide you through Canada’s complex – and ever-changing – regulatory landscape. We are here to assess potential issues, advise on regulatory regimes, assist with operations in accordance with approvals, and respond to issues should they arise.

With experience in over 100 regulatory processes in recent years across Canada, from coast-to-coast-to-coast, the Cassels national Regulatory Group is able to provide strategic advice to clients regarding regulatory matters – and act for clients before governing bodies – across Canada in order to obtain the approvals our clients need.

Projects

The Cassels Regulatory Group is a multi-disciplinary team of top-ranked lawyers across Canada, offering a wealth of expertise in the regulatory approval process of large-scale energy, natural resources, and infrastructure projects for the past 30 years.

In particular, we offer significant experience with the regulatory approval process for multi-billion-dollar infrastructure projects including oil and gas pipelines, Indigenous-backed energy projects, and major renewable energy generation and electricity transmission projects.

Drawing on the expertise of our top-ranked Mining Group, we are experienced in all regulatory aspects of resource development, including obtaining regulatory approvals associated with the development, acquisition, disposition, and operation of oil and gas and pipeline projects, as well as decarbonization. We have acted for proponents in some of the largest federal and provincial hearings for Canadian mining projects in recent years.

We are particularly proud to offer expertise in the key areas of energy transition and Indigenous-owned projects:

  • Energy Transition. We provide strategic regulatory advice to clients across the country on Canada’s transition to a low-carbon economy. Our lawyers have experience advising clients in the financial services, mining, oil and gas, renewable energy, and cleantech industries on energy transition matters, including carbon credit matters. We assist clients ranging from financial institutions to major wind and solar developers. We understand the evolving business reality that climate change – and the regulations and laws relating to it – presents.
  • Indigenous Owned Projects. The Cassels Regulatory Law Group is a national leader in advising on major Indigenous owned projects in the natural resources and infrastructure sectors. We act for industry, governments, and Indigenous groups in obtaining federal, provincial, and First Nation project approvals. We also offer specific expertise in obtaining land tenures on reserve lands.

Products

The Canadian regulatory and business environment in which companies that make, distribute, and sell regulated products (e.g., health products) operate is incredibly complex – and rich with opportunity. Cassels offers years of experience guiding clients through the complexities of administrative law in this sector and is proud to have been on the cutting-edge of new industries in this area, creating one the first top-ranked Cannabis Law Groups in the nation.

Our in-depth knowledge of the Canadian pharmaceutical, medical devices, and natural health products industry enables us to understand the business imperatives and issues facing our clients – and provide support on regulatory interpretation, compliance, and market access issues, including:

  • Health Canada license applications, approvals, and drug review regimes
  • Advocacy before regulators (including before the Patented Medicine Process Review Board and the Canadian Association for Drugs and Technologies in Health)
  • Assisting with compliance (including, for example, packaging and labelling reviews, record keeping obligations, audit procedures, incident reporting, and recall management)
  • Import/export issues
  • Public policy advice
  • Provincial drug benefit legislation, provincial formulary listings, and reimbursement issues
  • Advertising and marketing issues (including complaints governed by the Advertising Standard Council of Canada and the Pharmaceutical Advertising Advisory Board)
  • Procurement practices (including compliance with provincial supply chain guidance)

We understand both the opportunities and challenges our clients face when operating in this sector, including intricate and overlapping regulatory regimes. From pharmaceutical, medical devices, and natural health products to biotechnology, agriculture, and food – we have the experience needed to help you achieve the regulatory approvals needed to move forward.

Full-Service Firm, Dedicated Expertise

As part of a full-service firm, our Regulatory Group is supported by colleagues in other practice areas, ensuring seamless navigation of all related legal and business issues. We understand the ways in which these areas are interconnected, and we are able to call on our top-ranked partners from across the firm, including experts in:

If needed, Cassels is also able to call upon deep bench strength in litigation, including Class Actions and Product Liability.

In today’s world, it is more important than ever to engage a law firm and a legal team that can assess your situation from all angles and pull together the resources needed to ensure success. At Cassels, your success is your priority.