Psychedelic
Regulatory
Consulting
Psychedelic regulation is evolving faster than most compliance functions can track. Organisations that operate without current, jurisdiction-specific regulatory advice do so at significant risk. Psilonautica provides that advice.
Active Expertise In
United Kingdom
United States
Canada
Australia
New Zealand
10+
Years of psychedelic industry experience
6
Jurisdictions with active regulatory expertise
12
Clients advised across 12 countries
10+
Experienced contractors across the globe
the challenge
Regulatory hurdles aren't going away.
Federal and state frameworks can be contradictory in the US, while a variety of national approaches are emerging across Europe and Australasia.
1
Jurisdictional variation
A legal operating model in one country is often actively unlawful in another. Cross-border organisations cannot rely on generic legal advice.
2
Rapid, unpublicised change
Guidance documents, scheduling decisions, and licence conditions can change without significant advance notice. Regulatory monitoring is an active, ever-evolving exercise.
3
Asymmetric cost of non-compliance
A regulatory breach can result in loss of licence, prosecution, or reputational damage that far exceeds the cost of preventative advice. The risk-reward calculation is clear.
4
General counsel is insufficient
Most legal advisors lack specialist knowledge of psychedelic-specific frameworks. Technically correct advice can be strategically wrong for this sector.
Our Work
Specialist regulatory counsel for the psychedelic sector
Psilonautica provides regulatory consulting that combines scientific and clinical expertise with direct experience of the regulatory bodies and frameworks that govern this space. We advise on structure before you commit to it.
Regulatory Pathway Analysis
Mapping viable routes to legal operation, clinical authorisation, or product approval for your model and target jurisdictions before you commit to a structure.
Compliance Gap Review
Assessing your operating model against applicable regulations. We identify areas of exposure before they become enforcement issues, with a clear remediation roadmap.
Jurisdiction-Specific Guidance
Detailed advice on UK Home Office licensing, Oregon Measure 109, Colorado Proposition 122, Australian TGA scheduling, and clinical trial regulations across multiple markets.
Regulatory Monitoring
Tracking regulatory developments and notifying clients of changes that affect their operations so you are never caught off-guard by a policy shift.
Submissions Support
Advising on and reviewing materials submitted to regulatory bodies before they are filed.
Multi-Jurisdiction Work
Cross-border models require understanding how frameworks interact, not just where they exist. We advise regularly on international structures where jurisdictions converge and conflict.
how we work
Our Approach
Clear, structured engagement from first contact to outcome is the way we work with all clients.
1
You book an introductory call to assess your needs
We understand your operating model, target markets, and immediate regulatory questions before committing to scope.
2
We send you a plan of how we’d address those needs
A written scope, timeline, and fee structure agreed before any work begins. No surprises.
3
We gather experts and explore your goals
The right advisors for your specific jurisdiction, service type, and stage, tailored for your goals.
4
We achieve measurable results
Clear outputs delivered on schedule: pathway maps, compliance reviews, submission drafts, or monitoring reports.
The Team
Advisors with direct regulatory experience
Our regulatory work is led by researchers and practitioners with real relationships in the bodies that govern this space.
James Bunn
Founder · Operations & Compliance
Background in law with hands-on operational experience across the psychedelic and cannabis space. Manages regulatory navigation, team leadership, and compliance across Psilonautica’s international client base.
Dr. Eddie Jacobs
Ethicist · Regulatory Support
PhD in psychedelic therapy ethics from Oxford; postdoctoral fellow at Johns Hopkins Center for Psychedelic and Consciousness Research. Contributed to regulatory submissions, policy reports, and clinical trial design since 2019.
Dr. Rayyan Zafar
Psychopharmacologist · advisor
Neuropsychopharmacologist and postdoctoral researcher at Imperial College London. Senior Research Officer at Drug Science; research advisor to biotech firms and psychedelic clinics across multiple jurisdictions.
common questions
What to expect
Questions clients typically raise before engaging us on regulatory matters. Ask us anything else directly.
What jurisdictions do you cover?
Our active expertise covers the UK, the US, Canada, Australia, and New Zealand. For other jurisdictions, we advise on a case-by-case basis and indicate clearly where local specialist counsel may also be required.
Are you a law firm?
No. Psilonautica is a consultancy, not a law firm. Our regulatory consulting is strategic and evidence-based. For formal legal opinions or representation, we can advise on appropriate specialist legal counsel.
Do you operate across multiple countries?
Yes. Multi-jurisdiction analysis is one of the areas where specialist counsel is most valuable, because the interaction between frameworks is not always intuitive. We help you identify where requirements converge and where they conflict.
What does onboarding look like?
An introductory call to understand your operating model and immediate questions, followed by a written scope, timeline, and fee structure. No open-ended retainers unless that suits you.
Let's help you ahieve your goals
Whether you’re assessing a new jurisdiction, preparing a licence application, or reviewing an existing operating model, we’ll help you understand where you stand.