Helping companies around the world navigate the regulatory maze

Canadian Regulatory Services

Leverage Mapi’s years of experience working with Health Canada to navigate and expedite your company’s Canadian regulatory affairs program

We provide Canadian regulatory assessment, strategy, and guidance for the Canadian market, building scalable project models that meet its unique needs and budgets.

Our regulatory team consists of 120 consultants and advisors, including regulatory executive and director-level staff members averaging 15-35 years in Full Lifecycle Expertise service.

Comprehensive Submission Preparation & Publishing Services

  • Clinical trial applications (CTAs) and Canadian agent services
  • New drug and biologic submissions (NDS, SNDS, ANDS)
  • Prescription (Rx) to over-the-counter (OTC) switch submissions
  • DIN applications and notifiable changes
  • Medical device license applications
  • Natural Health Product (NHP) and food submissions
  • Cosmetics and new substance notifications
  • Agency liaison
  • Regulatory CMC consulting services
  • Full QA services, including drug establishment licensing, NHP Site Licensing and product release, implementation of Quality Systems and Site Audits
  • Reimbursement support
  • Due Diligence
  • Literature searches and FOI requests
  • Patented Medicine Prices Review Board (PMPRB) reporting
  • Preparation of Health Canada pre-meeting packages
  • Strategic Development Consulting

Let Mapi be your integrated regulatory solution for Canada

  • Experts that will clarify and negotiate the regulatory path for pharmaceuticals, biologics, NHPs, and devices
  • Specialist who can prepare and file submissions effectively
  • Problem-solving to achieve and maintain compliance at any stage of the product lifecycle

Case Study

The Canadian office of a multinational company—a long-term Mapi client and holder of a stable pharmaceutical portfolio—completed recent acquisitions that resulted in regulatory needs for many new products. The company’s medical director had minimal regulatory support and little experience with new drugs. To ensure accuracy and efficiency, our client sought regulatory support for due diligence, Health Canada interactions, New Drug Submissions (NDSs), clinical trials, and related activities.
Our client leveraged our consultant team’s more than 30 years of regulatory expertise, and received the support needed to complete due diligence, pre- NDS meetings with Health Canada, priority review requests, preparation of multiple NDSs, and management of files through to approval. The company also benefited from CDR support and adept problem-solving related to clinical trial inspection issues, referrals for microbial contamination resources, and eCTDs.
Our client got the experienced support it needed to successfully achieve priority review status and NDS approval. Additionally, operations continued to flow smoothly, and future success was ensured, through ongoing regulatory support and NDS file preparation from the Mapi consultant team.

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