Regulatory Atelier builds the regulatory function for sponsors developing first-in-class and controlled-substance medicines. Advising on a regulatory pathway and being accountable for the filing that travels it are two different jobs.

High-scrutiny therapies rarely fail because the science lacked promise. They fail because the care model, the risk controls, the site workflows, and the patient journey are designed too late to change anything.

Who I work with

Seed and venture-backed biotechs — sponsors that need the regulatory function built correctly before they can justify staffing it.

Public and global biopharma — program-level strategy, multi-region health authority engagement, and lifecycle submissions alongside an existing regulatory organization.

Investors and acquirers — regulatory diligence on assets where the pathway, not the data, is the variable that decides the deal.

Programs where regulatory strategy is the constraint — first-in-class mechanisms, Schedule I molecules, rare and pediatric populations, and therapies whose delivery model is as novel as the drug.

How engagements work

Fractional regulatory leadership — standing in as the regulatory function on a retained basis, from strategy through submission.

Program-scoped engagements — a defined deliverable with a defined end: a pathway, a briefing package, a REMS design, a diligence assessment.

Advisory and standing counsel — ongoing access for teams that have the function but need depth on controlled substances, psychedelics, or expedited pathways.

Diligence sprints — time-boxed regulatory assessment for in-licensing, partnering, and investment decisions.

Regulatory Intelligence & Development Strategy

For teams that need a clear, defensible path from complex science to approvable development strategy.

Regulatory Atelier designs integrated regulatory pathways that align clinical, nonclinical, CMC, safety, quality, and commercial considerations from the earliest stages of development.

  • End-to-end regulatory pathway design from IND/CTA through NDA/BLA/MAA, commercialization, and lifecycle management

  • Integrated nonclinical, CMC, clinical, safety, and regulatory strategies for first-in-class and high-complexity assets

  • Global development roadmaps across the US, EU, UK, Canada, Latin America, Japan, and key APAC markets

  • Regulatory intelligence systems that translate evolving FDA, EMA, MHRA, Health Canada, PMDA, ICH, and local expectations into practical development decisions

  • Board, investor, and diligence-ready framing of regulatory risk, timelines, evidence gaps, and value inflection points

  • Program sequencing, gap analysis, and cross-functional strategy across Regulatory, Clinical, CMC, Quality, Safety, Commercial, and Operations

Psychedelic, Neuroplastogen & Controlled-Substance Development

For programs where conventional CNS development models are not enough.

Regulatory Atelier advises teams developing MDMA-derived compounds, ibogaine, psilocybin, DMT, ketamine, non-psychedelic neuroplastogens, and next-generation CNS therapeutics.

  • IND/CTA strategy for psychedelic, neuroplastogen, and Schedule I programs across multiple regions

  • FDA, DEA, EMA, MHRA, Health Canada, PMDA, and other agency engagement strategy

  • Controlled-substance strategy, including research registrations, site licensing, quotas, import/export permits, diversion-control plans, storage, accountability, destruction, and chain of custody

  • Trial architecture for complex psychedelic and neuroplastogen studies, including durability, expectancy effects, functional unblinding, rater independence, psychotherapy or psychological-support separation, and functional outcomes

  • Development support for PTSD, treatment-resistant depression, anxiety, suicidality, trauma-related disorders, alcohol use disorder, opioid use disorder, polysubstance use, relapse prevention, and functional recovery

  • Documentation and operations calibrated for health authority review, DEA inspection, site execution, and investor diligence

  • Integration of AI/ML-enabled endpoints, digital measures, and real-world data concepts into credible regulatory narratives

REMS, Site-of-Care & Patient Access Infrastructure

For therapies where approval must be translated into safe, scalable delivery.

Regulatory Atelier helps sponsors build the operational architecture needed for complex treatment models, including supervised dosing, controlled distribution, monitoring, discharge, and follow-up.

  • REMS strategy, design, and operationalization

  • Site-of-care models for supervised or high-risk administration

  • Specialty pharmacy, investigational pharmacy, and controlled-distribution workflows

  • Accountability, storage, shipment, destruction, deviation, CAPA, and audit-response systems

  • Cross-functional operating models connecting Regulatory, Clinical Operations, Quality, Safety, CMC, Medical Affairs, Commercial, vendors, and sites

  • Launch-readiness planning for therapies with complex administration, monitoring, or risk-management requirements

Rare Disease, Orphan & Pediatric Strategy

For high-need populations where evidence generation, ethics, feasibility, and access must be planned together.

Regulatory Atelier supports rare, ultra-rare, pediatric, and underserved-population programs where small patient numbers, geographic dispersion, fragile populations, and complex benefit-risk considerations require careful regulatory architecture.

  • Orphan designation strategy and applications across the US, EU, UK, Canada, Japan, Latin America, and key APAC markets

  • Development plans for rare and ultra-rare diseases with small, fragile, pediatric, or geographically dispersed populations

  • Pediatric strategy, including Pediatric Study Plans (PSPs), Paediatric Investigation Plans (PIPs), deferral and waiver strategy, and lifecycle alignment

  • Evidence-generation strategies using natural history, external controls, registries, biomarkers, surrogate endpoints, and clinically meaningful outcomes

  • Harmonized rare disease and pediatric plans that preserve global coherence while respecting local regulatory requirements

  • Benefit-risk narratives grounded in clinical practice, ethics, feasibility, and desired labeling outcomes

  • Health authority meeting strategy for early alignment on endpoints, population, study design, and approval pathway

  • Single-patient and expanded access INDs for patients outside conventional options

Expedited Programs & Health Authority Engagement

For teams seeking acceleration without sacrificing regulatory credibility.

Regulatory Atelier helps sponsors identify, justify, and operationalize expedited and advanced regulatory pathways while ensuring that acceleration strategies remain evidence-based, inspection-ready, and commercially meaningful.

  • Strategy and dossiers for Breakthrough Therapy Designation, RMAT, Fast Track, PRIME, Accelerated Approval, Priority Review, and Priority Review Vouchers

  • FDA meeting packages, briefing books, questions, written responses, and follow-up strategy

  • EMA Scientific Advice strategy and cross-regional briefing alignment

  • MHRA, PMDA, Health Canada, and other global agency interactions

  • Controlled-substance agency interfaces, including DEA registrations, quotas, site inspections, import/export planning, and FDA/DEA alignment

  • Regulatory question strategy designed to generate actionable agency feedback rather than generic responses

  • Board and investor-facing interpretation of agency feedback, precedent, development risk, and value inflection points

AI-Ready Regulatory Strategy & Submission Infrastructure

For teams preparing regulatory programs for an AI-enabled review environment.

Regulatory Atelier helps sponsors build documentation, governance, and data structures that are clear, traceable, internally consistent, and defensible across human and AI-enabled review.

  • AI-ready regulatory documentation frameworks for submissions, briefing packages, response strategies, and internal governance

  • Submission narratives structured for consistency, traceability, and defensibility across modules and regions

  • Regulatory risk assessments for sponsor use of AI-enabled tools in development, documentation, data review, and decision support

  • Governance strategies to mitigate confidentiality, trade secret, hallucination, bias, and due-process risk

  • Internal operating models for responsible use of AI in regulatory intelligence, document drafting, quality review, and agency-response planning

  • Practical planning for FDA Elsa, agentic AI systems, and emerging regulatory review technologies

Track record

A 2026 accelerated approval — directed global regulatory strategy and lifecycle submissions for TRUTAKNA (atacicept-vymj) at Vera Therapeutics, which received FDA Priority Review in January 2026 and accelerated approval in July 2026.

Schedule I programs in four jurisdictions — regulatory consultant for EMP-01 (R-MDMA), VLS-01 (DMT), and DMX-1002 (ibogaine) at ataiBeckley, running concurrent filings before FDA, the EMA, the MHRA, and Health Canada with 100% on-time delivery.

Memorial Sloan Kettering's IND Office — one of the largest IND portfolios in the world; hundreds of oncology IND submissions across Phase I-III, as FDA and institutional liaison.

High-priority government development — contributed to the COVID-19 antibody program at Regeneron, conducted under Operation Warp Speed, supporting the regulatory intelligence and quality systems behind it.

Published on the policy environment — eleven analyses in Law360, Clinical Leader, and ABA Health eSource on psychedelic policy, expedited pathways, and AI-enabled FDA review.