Licensed to Deliver: DEL & EMA Explained

What Do DEL and EMA Licenses Mean for Our Day-to-Day Operations?

Our commercial manufacturing licenses allow us to manufacture and test cell therapy products for the commercial market. To achieve it, all our processes were reviewed and adjusted to meet the highest regulatory standards. The level of qualification/validation of manufacturing processes, equipment, facilities, analytical methods, and cleaning processes were entirely upgraded. The controls in place were tightened to demonstrate the integrity of the data supporting the quality of our products. Just as our DEL allows manufacturing and testing commercial cell therapy products in Canada, our EMA license also allows our clients to target the European market.

What Does This Change for You?

For our clients, these licenses remove significant regulatory hurdles. C3i can now manufacture everything from development runs all the way to commercial manufacturing. With our DEL and EMA licenses, you benefit from faster access to Canadian and European markets without the need for additional facility audits. This directly reduces the time, complexity, and cost of your regulatory submissions. Our licensing status adds credibility to your dossier. It strengthens the trust of your stakeholders, regulators, partners, and investors alike, who see these approvals as a hallmark of operational excellence and reliability.

Key Steps to Obtain These Licenses

Acquiring and maintaining those licenses is the result of huge investment, disciplined and organization-wide efforts. We’ve built and validated our infrastructure, implemented rigorous GMP systems, and established a comprehensive quality management framework. This includes extensive documentation, internal audits, and personnel training programs to ensure consistent compliance. Our facilities have successfully undergone Health Canada and EMA inspections, and we maintain compliance through self-identification, industry-recognized best practices, and alignment with mutual recognition processes. For our clients, this means partnering with a CDMO that has done the heavy regulatory lifting, ensuring you benefit from readiness without investing your own resources in site validation or regulatory prep.

How Do We Ensure Ongoing Compliance?

Our quality system applies continuous improvement principles and conformity level sustainability. The requalification program, as well as the environmental monitoring tendency reports, are examples of processes preventing drift and supporting the maintenance of established standards. In addition to regulatory inspections and clients’ audits, we apply a rigorous internal audit program ensuring adherence to procedures in place and quality culture vividness.

Global Credibility Starts with the Right Partner

Our regulatory standing significantly boosts our competitiveness and reputation on the global stage. Being licensed by Health Canada and the EMA makes us an attractive manufacturing partner not only in North America and Europe but globally. For you, this translates into a strategic advantage: our compliance can be referenced in your filings, accelerating approval timelines and enhancing credibility in business development activities. Whether you’re negotiating with global partners, planning tech transfers, or preparing for audits, working with a licensed CDMO sends a strong signal of quality, reliability, and inspection-readiness.

Our DEL and EMA licenses mean you’re working with a CDMO that is already positioned to support your product in major regulated markets. We’ve built the systems, passed the inspections, and committed to the culture so that you can move forward with confidence, speed, and regulatory peace of mind.

Ready to move your program forward with a licensed CDMO?

Let’s talk about your next steps. Contact us today.