ILLUMINANT Consulting
Guiding Regulatory Success in Regulatory Affairs and Drug Development with FDA, Health Canada, and Other Global Agencies
With over two decades of experience navigating complex regulatory environments across Canada and the U.S., Illuminant Consulting is your trusted partner in healthcare product development: from early-phase strategy (including FIH), Phase 1-3 and commercial market licensing.
SERVICES
At Illuminant Consulting, we offer expert regulatory affairs guidance tailored to the complex and evolving needs of the innovative pharmaceutical industry. With extensive experience across both Canadian and U.S. regulatory systems, we help small, medium and large pharmaceutical companies navigate every phase of product development—ensuring compliance, accelerating timelines, and maximizing the potential for regulatory development success. We also maintain a trusted network to facilitate integrated product development.
Strategic Regulatory Consulting
- Global regulatory development strategy for innovative pharmaceuticals (biologics and small molecules) and drug/device combination products
- Regulatory Filings with a US & Canada focus
- IND/CTA, Pre-/CTAIND, EOP1 to 3, and NDA/BLA/NDS/SNDS and regulatory maintenance support
- 505 b(1) and 505(b)(2) strategy and licensing applications
- FDA (INTERACT, Type A-D interactions) and Health Canada (Pre-CTA/Pre-NDS) meeting briefing document, team preparation, and review
- Regulatory Intelligence
- Facilitating Agency Inquiries and composing responses in collaboration with integrated product development team
- Agent Representation and Lead Contact
- Acting Head of Regulatory Affairs / Loaned-Executive Services
- Regulatory Crisis Management
Lifecycle Product Support
- Early development strategy (505(b)(1) / 505(b)(2))
- Investigational drug setup and compliance
- Regulatory maintenance & variations
Specialty Expertise
- Innovative Biologics, small molecules, combination
- Contrast imaging agents, diagnostic and therapeutic radiopharmaceuticals
- Anti-infectives
- Rare disease, oncology, CNS, autoimmune, mental health
- Etc (please inquire)
Client Support
- Cross-functional team leadership
- Vendor Management, as needed
Learn more about our services
Partnering Opportunities
Illuminant Consulting, with experienced leadership has the opportunity to join pharmaceutical companies as a partner to monetize intellectual property in the pharmaceutical space. Intellectual property holders and investors are welcome.
We are also interested in expanding our drug development and trusted Regulatory Affairs and drug development network.
Please contact us if you are interested in learning more about partnering with Illuminant Consulting and Drug Development.
About Jason J. McEwan
Principal Consultant, Regulatory Affairs
Jason brings 20+ years of deep, cross-border expertise in regulatory affairs, working both within Health Canada and as a consultant and strategic lead for global pharmaceutical and biotech companies.
He has led interactions with the FDA (CDER/CBER) and Health Canada, developed regulatory strategies for small molecules, biologics, gene and cell therapies, and has extensive experience in innovative, niche, and specialty product development—including anti-infectives, radiopharmaceuticals, diagnostic imaging, and vaccines.
A recognized problem solver and communicator, Jason has helped secure approvals for first-in-class products, supported due diligence activities, and guided companies through complex regulatory pathways and special designations (ODD, QIDP, Breakthrough, Priority Review, etc).
CONTACT
Let Illuminant Consulting light your path for Regulatory Affairs and Innovative Drug Development.