Karina Lahnakoski B.Sc., MBA
About KL Advisory
Advising regulated scientific companies for over 25 years
Your Partner in GMP & AI Excellence
25 Years of Expertise
Specialized in regulated scientific industries (Pharmaceutical, Biotechnology, Cannabis), focusing on quality, compliance, and operational excellence.
Proven Leadership in Consulting
15+ years consulting experience, including as a former Partner at Deloitte, guiding businesses through complex regulatory landscapes.
Experienced Implementation Leader
Partnered with multidisciplinary teams across North America to successfully deliver large-scale, regulatory-aligned implementations.
Certified & Committed to AI Innovation
Certified in AI Consulting, Data Science, and Machine Learning -bringing cutting-edge insights to your organization.
Sample Projects
Establish Drug Establishment Licence (DEL)
Defined and operationalized QMS for a new contract drug manufacturer, passed DEL inspection in 12 months, validated process and reached international supply.
Establish Regulatory Path for un-Regulated IVD in EU
Led commercialization/QMS start‑up for a U of Toronto IVD spin‑out; engaged EU Commission working group to align assay common technical specification, enabling eventual EU market access.
Fractional AI Leadership
Act as AI advisor on various projects including software for patient access and triage into hospital websites providing regulatory and strategic direction prior for proof of concept build and go to market planning.
Manage Plant Closure and Product Technology Transfer Progam
Achieved a business directive to close a large manufacturing site within 18 months by leading the technology transfer of 14 commercial drug products with regulatory submissions filed and without supply chain disruption.
Build Start-up Compliance Consulting Firm
Built the compliance and regulatory consulting unit of a new consulting firm prior to regulatory changes that legalized cannabis in Canada which required setting the standards for hundreds of clients, cumulating in sale to Deloitte
The Team Behind The Work
While Karina leads each engagement, she works within a trusted network of experienced consultants, each bringing domain expertise across quality, compliance, data science, and AI implementation. This model allows our work to stay agile, scalable, and focused – assembling the right team for each project while maintaining the strategic oversight and consistency clients expect.
Karina's Values
Compliance isn’t just technical, it’s human
She believes in transparency, where communication is clear, AI systems are explainable, and outcomes are measurable.
Humility drives her approach: she listen first, collaborates openly, and never assumes one-size-fits-all.
Above all, she act with integrity – honouring the trust clients place in her by aligning innovation with accountability every step of the way.
What KL Advisory Offers
- GMP Implementation and Support
- AI Integration into Regulated Workflows
- Fractional Leadership: QA/Regulatory & AI Strategy
- GMP/GACP/GPP Auditing
- Inpsection Support/Response/Recovery
- Commercialization Programming
Karina is an active speaker and educator. To invite her to an event, please contact her.
Some Numbers
Over 25 years of scientific leadership and consulting…
Client Projects Managed
Training Hours in AI
Educational Presentations for Industry
Hosted Audits/Inspections
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