Regulatory & Development Strategy for Psychedelic Therapies
Backed by the most extensive experience across compound types including MDMA, ketamine, and psilocybin, MMS supports sponsors advancing treatments for a range of indications such as PTSD, depression, and substance use disorders.
Why Psychedelics Require Specialist Support
Psychedelic therapies offer real potential, but also come with unique development hurdles. From subjective endpoints and high-risk patient dynamics to a shifting regulatory landscape, success in this space demands deep, specialist experience.
At MMS, we understand:
- The complexities of guided therapy endpoints and non-standardized trial outcomes
- How to address behavioral and compliance risks in vulnerable patient populations
- What regulators expect, including how to operationalize 2023 FDA guidance
Need specialist insight for your psychedelics development program? Book a consultation with our experts.
What Differentiates MMS From Other CROs?
Expertise in key compounds
MMS is the leading CRO in psychedelic drug development, with unmatched expertise in key compound types including MDMA, ketamine, and psilocybin. We’ve supported some of the most advanced clinical programs across indications such as PTSD, depression, and substance use disorders, guiding sponsors through development planning, data strategy, and regulatory submission.
Regulatory and risk oversight
From regulatory planning and Advisory Committee preparation to NDA submissions and REMS design, we combine proven FDA engagement with real-time data oversight through Datacise®.
Industry-wide collaboration
We collaborate with institutions like the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and leading academic key opinion leaders, bringing strategic insight, credibility, and influence across the full development lifecycle.
Our Services
End-to-end support for New Drug Applications, including coordination of submission strategy, Module 2 and 5 content development, and REMS planning and implementation tailored to the psychedelic treatment landscape.
Strategic support from pre-IND through to NDA, including FDA meeting preparation, briefing packages, regulatory submissions, and REMS design. MMS also provides expert guidance on interpreting and operationalizing evolving drug development guidance.
Using our proprietary KerusCloud® platform, MMS enables data-driven protocol design and trial simulation, helping sponsors optimize endpoint selection, reduce risk, and model key trial outcomes before first-patient-in.
Full-service biometrics support including data management, biostatistics, and statistical programming. Our team ensures high-quality, submission-ready data and proactive oversight across the trial lifecycle.
Comprehensive safety surveillance and expert authoring of protocols, narratives, CSRs, IBs, and DSURs. MMS brings deep therapeutic understanding and regulatory alignment to all safety and writing deliverables.
gain insights from our psychedelics experts
Psychedelic Drug Development Part I: Understanding Benefit–Risk
Explore key regulatory considerations in psychedelic development, with a focus on benefit–risk assessment and how it influences trial design and approval strategies.
Psychedelic Drug Development Part II: Nonmedical Use and Labelling
Understand FDA perspectives on “nonmedical use” in psychedelic therapies and how evolving terminology impacts labelling and risk communication strategies.
Priority Review Vouchers: Psychedelic Challenges and Solutions
Learn how the FDA’s National Priority Review Voucher (NPRV) program intersects with psychedelic drug development and what sponsors need to prepare.
WANT TO FIND OUT MORE?
Download our Advancing Psychedelics Therapies brochure to find out more about our:
- Regulatory leadership
- Trial design expertise
- End-to-end support across MDMA, ketamine, and psilocybin development
Discover how our teams help sponsors navigate complex challenges unique to psychedelic therapies, from guided therapy endpoints and behavioral risk to FDA Advisory Committee preparation and REMS planning.
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