Federal and state frameworks can be contradictory in the US, while a variety of national approaches are emerging across Europe and Australasia.
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.
Mapping viable routes to legal operation, clinical authorisation, or product approval for your model and target jurisdictions before you commit to a structure.
Assessing your operating model against applicable regulations. We identify areas of exposure before they become enforcement issues, with a clear remediation roadmap.
Detailed advice on UK Home Office licensing, Oregon Measure 109, Colorado Proposition 122, Australian TGA scheduling, and clinical trial regulations across multiple markets.
Tracking regulatory developments and notifying clients of changes that affect their operations, so you are never caught off-guard by a policy shift.
Advising on and reviewing materials submitted to regulatory bodies before they are filed.
Cross-border models require understanding how frameworks interact, not just where they exist. We advise regularly on international structures where jurisdictions converge and conflict.
Clear, structured engagement from first contact to outcome is the way we work with all clients.
We understand your operating model, target markets, and immediate regulatory questions before committing to scope.
A written scope, timeline, and fee structure agreed before any work begins. No surprises.
The right advisors for your specific jurisdiction, service type, and stage, tailored for your goals.
Clear outputs delivered on schedule: pathway maps, compliance reviews, submission drafts, or monitoring reports.
Our regulatory work is led by researchers and practitioners with real relationships in the bodies that govern this space.
Questions clients typically raise before engaging us on regulatory matters. Ask us anything else directly.
Whether you are assessing a new jurisdiction, preparing a licence application, or reviewing an existing operating model, we will help you understand where you stand.
