No matter what therapeutic area you are looking to market in Canada, Progress will assist with the planning and execution of a seamless market access strategy. From product licence applications through our trusted partners, to labelling review, Health Canada review timelines and beyond, we will work with your team to ensure all aspect of product launch in Canada are considered. Here are some ways that we can work with you to formulate your Canadian Market Access Strategy:
- Initial documentation review to determine any gaps that could present issues, and slow down processes.
- Timeline overview so you have a clear picture of how long Health Canada will take to complete various review processes such as Drug Establishment Licence Amendment reviews, Site Licence reviews and submission reviews.
- Review of labels for Canadian products, to ensure details are compliant with Health Canada regulations.
- Liaison with testing labs to ensure method transfer timelines align with launch plans.
- Liaison with warehousing partners to ensure timelines align with launch plans, and the correct facility is selected for the requirements of your products and volume.
PTI's expertise spans a broad spectrum, covering everything from common remedies to rare disease treatments. Our comprehensive approach ensures that a correct path to market is selected for your specific product and timelines, aligning seamlessly with the expectations and regulations set forth by Health Canada.
Navigate Canadian Market Entry with Ease
Partner with Progress Therapeutics for seamless compliance and expert handling across all healthcare products. Let's elevate your success together.
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Benefits of Choosing Progress Therapeutics
Embark on a journey with Progress Therapeutics, where your goals align with our mission to redefine healthcare accessibility in Canada. Let us assist you in making a positive impact on the health landscape of Canada.
For many companies, global expansion of their product and brand is a primary objective of their growth strategy. Successfully accessing foreign markets with your product requires a great deal of capital and knowledge of the new market. These two issues are often the limiting factors for companies looking to expand.
Clients using Progress Therapeutics for their importer of Record activities do not incur the expenses of carrying a full-time staff for Quality, Regulatory, and Office Management. Our clients do not have the need to maintain a physical address, or Establishment Licence. In essence, Progress Therapeutics acts as an extension of your company in Canada.
Our clients gain access to our infrastructure, extensive regulatory knowledge and partnerships, at a fraction of the cost to maintain their own physical presence in Canada. Whether you are looking to form a long-term business relationship with Progress Therapeutics, or use our services during the New Drug Submission process, or until you have a foothold in the Canadian market, we look forward to assisting you with your expansion plans.
The repercussions of non-compliance are not merely financial but can extend to reputational damage. Since our inception, Progress has built a strong reputation around compliance. We will employ this same attention to detail and compliance when working with your organization and products to ensure we uphold your reputation, as well as our own.
We alleviate burdens associated with annual licensing, compliance procedures, and regulatory obligations. Progress offers our clients a strategic, cost-effective approach to navigating the complexities of the Canadian regulatory landscape. When you work with Progress you will not be subject to many of Health Canada’s yearly fees for licensing, the need to hold your own Canadian establishment, the requirement for Canadian Quality Assurance staff on site, and regular Health Canada inspections. This means you can achieve market access with less capital expenditure and ongoing costs.
Our proactive approach is designed to not only sidestep unnecessary delays and expenses but also to instill confidence in our clients, assuring them that Progress is not just a service provider, but a strategic partner deeply invested in the success of their endeavors. Our qualified staff will ensure that your products receive the attention needed to meet necessary deadlines, clear regulatory and quality hurdles and keep your products in stock and accessible to Canadians.