If you're a pharmaceutical or biotech company planning to sell products in Canada, one of the first regulatory questions you'll run into is whether you need a Drug Establishment Licence (DEL), and if so, how to get one. The answer depends on your business model, and getting it wrong can delay a launch by months.
What Is a DEL, and Who Needs One?
A Drug Establishment Licence is issued by Health Canada and is required for companies that fabricate, package/label, test, import, distribute, or wholesale drugs in Canada. If your company falls into any of these activities and doesn't already hold a DEL, you generally have two options:
- Apply for your own DEL. This process can take significant time, requires an established quality system, and typically only makes sense if you plan to run a full Canadian operation long-term.
- Partner with a company that already holds a DEL. This lets you bring products to market without the overhead of building and maintaining your own licensed facility.
Why Many Companies Skip Getting Their Own DEL
For pharma and biotech companies entering Canada for the first time, or running smaller volumes, setting up an independent DEL-holding operation often isn't practical. It means:
- Paying tens of thousands of dollars in application fees before any product moves
- Standing up (or contracting) a GMP-compliant facility
- Building a Canadian quality system from scratch
- Navigating an application and inspection timeline that can stretch launch dates well beyond a company's target window
For many companies, especially those testing the Canadian market with a smaller shipment or a single product line, working with an established DEL holder is significantly faster, lower-cost, and lower-risk.
How a Commercialization Partner Helps
Working with a partner who already holds a DEL means your product can move through import, storage, and distribution without your company needing its own licence in place. A good partner will typically handle:
- Importation: acting as Importer of Record where needed
- GMP-compliant storage and distribution: including cold-chain and temperature-controlled logistics where required
- Regulatory and quality support: so your product stays compliant as it moves through the Canadian supply chain
- Market access and commercialization support: helping you go from "approved" to "actually available to patients"
This is particularly useful for companies running pilot shipments to test demand before committing to a larger, recurring supply chain, a common first step before scaling into regular orders.
What to Look for in a DEL Partner
Not all DEL holders offer the same scope of service. When evaluating a partner, it's worth asking:
- Do they hold an MDEL or DEL relevant to your product category?
- Can they support both one-off pilot shipments and larger recurring volumes?
- Do they offer end-to-end support (importation, storage, distribution, and regulatory), or just one piece of the puzzle?
- What's their experience with your specific product type (biologics, specialty medicines, generics, etc.)?
How Globyz Can Help
Globyz BioPharma Services holds licensing in Canada and offers end-to-end commercialization support for pharmaceutical and biotech companies entering or expanding in the Canadian market, from importation and GMP-compliant 3PL warehousing to regulatory affairs support and market access. Whether you're planning a small pilot shipment to test the market or a full commercial launch, our team can help you move faster and avoid the upfront cost of building your own licensed infrastructure.
Curious whether your product needs a DEL, or whether a commercialization partner is the right fit? Contact Globyz to talk through your specific situation.