A Partner Who Understands the
Clinical and Regulatory Pathway
As one of Canada’s leading not-for-profit life sciences commercialization organizations, we deliver faster, more cost-effective and highly flexible
solutions—whether you’re advancing a pharmaceutical, biologic,
natural health product, medical device & diagnostic or other health technology.
We have expertise across all services under one roof—giving you a seamless,
end-to-end experience from discovery to commercialization. From early classification and customized regulatory roadmaps to global submissions and agency interactions, we support you through each step to meet requirements from
Health Canada, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and others.
Medical Devices & Diagnostics
Health Canada
- Medical Device License (MDL) Applications
- Medical Device Establishment (License (MDEL)
- Investigational Testing Authorization (ITA)
- Small Business Status Applications
- License Renewals and Amendments
FDA
- 510 (k) Notification
- Premarket Approval (PMA)
- Investigational Device Exemption (IDE)
- De Novo Classification Request
- Establishment Registration and Device Listing
- 513 (g) Submission
- Small Business Status
- Pre-Request for Designation (RFD) and Q-Submission Program
Drugs
FDA
- Investigational New Drug (IND) submissions including Research INDs
- New Drug Application (NDA)
- Pre-IND/NDA and Type A/B/C meetings
- Orphan Drug Designation
- INTERACT meetings
- Request for Designation (RFD) / Pre-RF
Natural Health Products
Health Canada
- Product License Application (PLA)
- Pre-PLA meeting
- Site License Application
- Ingredient Submission Requests
Regulatory Services
Regulatory & Quality Strategy and Planning
There’s often more than one pathway to market. We work with you to understand your product and end users, defining the most efficient, tailored route for your life sciences innovation.
- Regulatory Strategy: Developing customized regulatory strategies tailored to specific product types, including pharmaceuticals, medical devices & diagnostics, and natural health products.
- Regulatory Gap Assessments: Evaluate the current regulatory status of your product and identify potential compliance gaps or obstacles to market approval.
- Regulatory Roadmap: Identify applicable regulatory requirements and product specific standards to guide the design and development from inception through to commercialization.
Regulatory Submissions and Interactions
From initial communications and filings through to commercialization and post market surveillance, our team can support all your regulatory needs with Health Canada, FDA, EMA and others throughout the entire product lifecycle.
- Regulatory Document Preparation and Management: Preparation of dossiers, briefing packages, and other regulatory documents with a strong focus on compliance.
- Regulatory Submissions: Preparation and support with the submission of regulatory applications.
- Regulatory Interactions & Communications: Directly interact, or support, with regulatory agency correspondence through email, phone or formal meetings.
Healthcare Product Classification
When developing a new product, it is often difficult to determine the category that it belongs to when it comes to regulatory agencies. We are here to help you navigate the regulations to determine whether you have a natural health product, consumer product, software as a medical device, diagnostic, drug or another type of healthcare product, we can support you.
- Classification Assessment: Evaluate the product against applicable regulatory standards and jurisdictional requirements to determine appropriate classification to support strategy and planning decisions.
Meet Our Senior Leaders and Contacts
Launa Aspeslet
Chief Translational Officer
Read bioabout Launa Aspeslet Launa Aspeslet
Chief Translational Officer
Launa Aspeslet is an accomplished life science executive and board member with over 20 years of leadership experience in scaling early-stage organizations to sustainable growth and maturity. She excels in multi-stakeholder environments, new product development, and guiding entrepreneurs through organizational transformation.
Currently, Launa also serves as Senior Clinical & Regulatory Advisor to Model Medicines and a Board member of Edmonton Unlimited. She recently acted as interim CEO at Edmonton Unlimited and has held roles as COO at Hepion Pharmaceuticals, CEO of TRIO, and COO at Isotechnika Pharma. She has also provided strategic consulting for various early-stage drug and medical device companies. During this time, Launa has led teams to conduct over 50 clinical trials, enrolling more than 10,000 patients across 20 countries.
She holds a BSc in chemistry from the University of Lethbridge and a PhD in Pharmaceutical Sciences from the University of Alberta, along with a Regulatory Affairs Certification (RAC).
John Huang
Regulatory Affairs Specialist
Located in one of Canada’s
Fastest-Growing Life Sciences Hubs
Located in Edmonton, Alberta, API sits at the heart of one of Canada’s
fastest-growing life sciences ecosystems. Our region is experiencing a
surge in investment, with new infrastructure, expanded research capacity,
and a strong pipeline of talent. Anchored by globally recognized institutions
like the University of Alberta, Life Sciences Campus at the Edmonton Research Park and surrounded by a growing community of startups and a tightknit entrepreneur community, Edmonton offers a uniquely collaborative
environment for innovation.
Edmonton is also a key part of the Canadian Critical Drug Initiative (CCDI),
a nearly $200 million project led by our team at API in partnership with the
University of Alberta. Through the CCDI, we’re developing an integrated research, commercialization and manufacturing cluster within the Edmonton Metropolitan Region.
As a Canadian-based CRO and CDMO, we also offer cost advantages and access to international markets—making us an ideal partner for both domestic and global companies looking to scale their therapeutic innovations.
The Canadian Critical Drug Initiative
Integrated End-to-End Support for Life Sciences Innovation
Beyond regulatory strategies and submissions that align with your goals, our wrap-around, integrated services—including Early Discovery & Development, Quantitative Solutions, Clinical Support, and Contract Manufacturing—support your life sciences product at every stage. From discovery to clinical strategy and scalable manufacturing, our team of problem solvers and cross functional collaborators deliver comprehensive services that support innovators at every stage, accelerating your journey to commercialization.
Clinical & Quantitative Solutions
We specialize in guiding companies through preclinical, clinical, and market safety phases, providing expert support at every stage of development
Discovery & Development
We specialize in guiding companies through preclinical, clinical, and market safety phases, providing expert support at every stage of development.
CDMO Services
We deliver flexible solutions for clinical and commercial manufacturing.
Learn more about our services for different therapeutic areas
Pharmaceuticals & biologics
Discover how we can help you accelerate the drug development process.
Medical devices & diagnostics
Learn how we can help you navigate the intricacies of advanced medical technology.
Natural health products
Find out how we can empower your consistent NHP development.
Health technologies
See how we support the evolving landscape of health technologies.
Ready to start your regulatory journey?
Contact us today for a free consultation and discover how we can accelerate your life sciences product path to the clinic.
Get started