Commercializing in Canada: Regulatory Publishing and Submissions

The Canadian pharmaceutical market has its own complex set of rules and regulations. Manufacturers must verify that everything they submit to Health Canada complies with the relevant submission guidance, contains all the necessary components, and gets completed in a timely manner. In this Q&A, Justin Evans, Director of Regulatory Operations at TPIreg, a division of Innomar Strategies, talks about how his team helps ensure compliance and eases the path to commercialization in Canada.

Q: How do you guide clients through the commercialization process in Canada? 

Justin Evans: We work on commercialization in both Canada and the United States. We’re able to use our expertise to guide clients through the complex technical compliance issues and submission processes associated with bringing a new product to market.

For instance, Health Canada requires manufacturers to submit what is known as a product monograph for each pharmaceutical product, describing its properties, indications, conditions of use and other information. We ensure that submissions are completed in the required electronic common technical document (eCTD) format and sent securely over the common electronic submissions gateway to Health Canada. As the product monograph is a key document within Health Canada submissions, it often requires multiple submission cycles to gain agreement with the Agency prior to approval. We navigate this process and manage the lifecycle on behalf of our clients to ensure a successful outcome.

We also stay ahead of the curve to ensure our clients will be in compliance with upcoming regulatory changes. For instance, we already prepare structured product labeling (SPL) to comply with FDA guidelines in the U.S., and Health Canada is also going to adopt a similar structured format for product monographs. We have made provisions to be able to support these types of submissions and provide advice to help clients adapt to these changes.

Q: What are some of your services that clients particularly appreciate? 

JE: I think it's our range of expertise that clients appreciate the most. We can provide strategic regulatory advice, guidance on submission standards, assistance with clinical trial applications, and post-market life cycle management, among other services. In addition to managing eCTD and SPL submissions, we can also assist with non-eCTD electronic submissions such as medical device applications, clinical trial applications and submissions for natural and non prescription health products.

Q: What question do clients ask you the most?

JE: The most common question is, “How much time will this take?" The answer depends on a couple of factors. The first factor is the size of the project. Some submissions may include 200 documents, and others may include 1,000 documents. Some documents are two pages; some are 1,000 pages.

The second factor is which specific services clients are seeking. Some clients want us to handle all parts of the process of completing a submission to Health Canada, from formatting to ensuring submission readiness to building an eCTD. We want to make sure every submission is professional-looking, complete and compliant. We also make sure that we're doing exactly the job that the client has requested of us without adding anything that will be too costly or time consuming.

We pride ourselves on quick turnarounds. Often our clients have time constraints especially when they are nearing the end of the commercialization process. They appreciate our calm, prompt and reliable approach to ensure their submission is completed within the project timeline. Our clients benefit from us having staff on both the east and west coasts, which provides a few extra hours to the working day.

TPIreg provides high quality, cost effective submission services for companies looking for a reliable regulatory service provider to ease the path to commercialization in Canada.