SOLUTIONS

Psychedelic Drug Development

Extensive expedited program submissions experience with global health authorities.

MMS is always available and responsive to my inquiries and requests, whether they are related to a psychedelics drug development project or to any other matter.

Head of Regulatory

Mental Health Sponsor

Psychedelic drug development is experiencing intense and renewed interest from the pharmaceutical industry, and the potential for these therapies to target areas of urgent unmet need. Opportunities exist for prepared sponsors to take advantage of expedited approval pathways and reach the market ahead of the competition.

With our extensive knowledge of expedited programs, psychedelics, and psychiatric indications, we can help clinical trial sponsors gain new drug approval by:

Achieving initial fast track and breakthrough designations
Leveraging designations to accelerate clinical development though early and effective health authority interactions
Preparing for the challenging timelines associated with Priority Review, rolling submissions, and Advisory Committees
Sharing industry best practices and submission experience

Why choose MMS?
Expedited pathways impose additional urgency on every discipline within drug development. At MMS, we are uniquely positioned to address the challenges that are inherent in psychedelics drug development through 4 key differentiators:

Experience developing landmark psychedelics NDA submission
Proactive focus on data quality to ensure efficiency and smart decision-making
Strong clinical understanding of treatment from beginning to end of psychedelic therapeutics and drug development
Cross-functional working relationships and approaches to fill gaps across teams and disciplines

CMC

Whether preparing a Phase 1 CMC package or a Module 3 build for marketing application, our expert CMC consultants and writers will help you navigate GMP requirements, right of reference approaches, and unique challenges such as guidelines for botanical drug development.

Nonclinical

Our team of nonclinical strategists, writers, and data specialists will help you achieve agreement from global health authorities and conduct your pre-clinical program with confidence through the following:

Effective use of Type-D meetings to obtain early agreement on the use of published literature and reference submissions to effectively leverage prior nonclinical and clinical data in support of IND enabling studies.
Early discussions of relevant non-clinical requirements to ensure study designs are appropriate to planned indication and clinical dosing regimen.
Worry-free IND preparation from experienced nonclinical writers and strategists.

Clinical Trial Design & Compliance

Create SOPs proactively to ensure that compliance needs are met
Build credible development program for potential partners and investors
Develop regulatory and compliance strategy in parallel for synergistic benefits

MMS Regulatory Affairs

Strategic consulting and direct regulatory communication
Coordinating submissions in tandem with your clinical or regulatory groups
Consolidating data entry and uploads to CTIS, leveraging our CTIS tracker as a reliable reference for all updates
Efficient portal monitoring and document management

MMS Clinical Trial Transparency

A seasoned team adept at personal protected data (PPD) and company confidential information (CCI) redactions
Orchestrating reviews with your clinical, regulatory, and legal entities
PoCs skilled at guiding, facilitating, and pinpointing reasons for CCI
Crafting consistent dossiers reusable for other disclosure needs like ClinicalTrials.gov, Health Canada PRCI, and EMA Policy 0070 submissions
Comprehensive dossier disclosure support

MMS Regulatory and Medical Writing

Skilled medical writers utilize lean authoring techniques and practices in line with CTR
GAP analysis and refining your templates for portal compatibility
Precision authoring to limit the reliance on PPD and CCI