Psychedelic
Clinic
Consulting
Establishing a psychedelic therapy clinic is a complex operational challenge. It requires clinical governance expertise, regulatory authorisation, trained staff, appropriate infrastructure, and a patient pathway that meets both therapeutic and compliance standards. We help clinic developers move from concept to operation with fewer costly detours.
What We’ve Done
Feasibility & Market Assessment
Regulatory Pathway Planning
Clinical Governance Design
Staffing & Training Strategy
Patient Pathway Development
10+
Years of psychedelic industry experience
12
Clients advised across 12 countries
15+
Years of clinical trial management expertise
10+
Experienced contractors across the globe
the challenge
Clinic development has a high failure rate
The psychedelic therapy clinic space is attracting serious investment and genuine clinical talent. It’s also generating many projects that stall or fail before opening, not because the clinical rationale is weak, but because the operational and regulatory infrastructure isn’t established correctly from the outset.
1
Regulatory authorisation is incredibly complex
Controlled substance licensing, clinical governance requirements, and the conditions attached to operating licences vary significantly by jurisdiction and require specialist navigation, not general healthcare compliance experience.
2
Staffing and training requirements are evolving
As formal certification standards emerge, particularly in Oregon and Colorado, the requirements for therapist credentialling are changing. Clinics built on current assumptions may need to rebuild compliance infrastructure as requirements tighten.
3
Patient pathway design is both clinical and regulatory
The processes governing assessment, preparation, dosing, and integration must meet clinical best practice standards and, increasingly, formal regulatory requirements. Getting this wrong creates clinical risk and licence exposure simultaneously.
4
Environment requirements are highly specific
Regulatory guidance on space design, monitoring, and safety procedures is now detailed enough to require specialist input during the design and fit-out stage, not after the space is built.
Our Work
End-to-end clinic consulting from feasibility to operation
Psilonautica works with clinic developers, healthcare organisations, and investors to build psychedelic therapy services that are clinically sound, regulatory-compliant, and operationally sustainable. We work with clients at the pre-launch stage and with operational clinics seeking to review and strengthen their governance or clinical model.
Feasibility & Market Assessment
Evaluating whether a proposed clinic model is viable in your target jurisdiction, given current regulatory conditions, patient demand, and the competitive landscape, before capital is committed.
Regulatory Pathway Planning
Mapping the specific licences, authorisations, and approvals required, and advising on the most efficient sequence for obtaining them to avoid delays and unnecessary reapplications.
Clinical Governance Design
Developing the policies, procedures, and oversight structures that satisfy both clinical standards bodies and regulatory requirements — built around your specific service model and patient population.
Staffing & Training Strategy
Advising on clinical team structure, credentialling standards, and approved training programmes that satisfy licensing requirements in Oregon, Colorado, and other emerging markets.
Patient Pathway Development
Designing the full patient journey from referral and assessment through preparation, dosing, and integration, in compliance with applicable clinical and regulatory standards.
Site Design & Environment
Advising on spatial and environmental requirements for compliant and therapeutically effective dosing rooms and clinical spaces, including ketamine, psilocybin, and MDMA service contexts.
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 clinic model, target jurisdiction, and development stage 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 clinical, regulatory, and operational advisors for your specific service type and jurisdiction, assembled specifically for your goals.
4
We achieve measurable results
Clear outputs: feasibility reports, regulatory roadmaps, governance frameworks, patient pathway designs, delivered on schedule.
The Team
Advisors with clinical and operational depth
Our clinic consulting draws on direct clinical research management, regulatory affairs, and healthcare governance experience across the psychedelic therapy sector.
James Bunn
Founder · Operations & Strategy
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.
Tali Avron
Clinical Trials Manager
15+ years leading clinical trials across diverse therapeutic areas with a strong focus on mental health and psychedelic-assisted therapies. Has managed end-to-end clinical programmes for pharmaceutical companies, CROs, and biotech startups.
Dr. Rayyan Zafar
Clinical Researcher · Advisor
Neuropsychopharmacologist at Imperial College London; Senior Research Officer at Drug Science. Research advisor to psychedelic and cannabis-focused biotech firms and clinics across multiple jurisdictions.
common questions
What to expect
Questions clients typically raise before engaging us. Ask us anything else directly.
We're at a very early stage. Is it too early for a consultant?
No. It’s often more cost-effective to engage at the concept stage than after structural decisions have already been made. Early-stage consulting typically focuses on feasibility and regulatory pathway planning, which shapes the entire development process. Correcting foundational errors later is significantly more expensive than avoiding them.
Do you cover ketamine clinics as well as psilocybin and MDMA?
Yes. Ketamine-assisted therapy is the most established psychedelic therapy modality currently operating in clinical settings, and our regulatory and governance expertise is directly applicable.
Can you help with investor materials for a clinic?
Yes. We can advise on the clinical and regulatory components of investor materials, ensuring the operating model is accurately described and that any regulatory or clinical claims are defensible. We work alongside commercial and financial advisors rather than replacing them.
What does a typical development-stage engagement look like?
Most development-stage engagements begin with a feasibility and regulatory scope review, producing a clear picture of what is required in your specific jurisdiction. From there we move into deeper advisory work on whichever components are most pressing: governance design, patient pathway, staffing, or site. Pace and scope are shaped by your timeline and budget.
Let's help you ahieve your goals
A well-built psychedelic therapy clinic is achievable. But it requires getting the foundations right.