Bring Regulatory Atelier in when the program is promising, complex, and under scrutiny.

Regulatory Atelier works with biotechnology, pharmaceutical, investor-backed, and advisory teams developing high-complexity therapies that require integrated regulatory strategy, health authority engagement, controlled-substance planning, site-of-care design, or execution-ready development architecture.

Odette is especially well suited for teams facing questions such as:

• What is the most credible regulatory path for this asset?

• How should we sequence IND/CTA, CMC, nonclinical, clinical, and health authority work?

• How do we design a psychedelic, neuroplastogen, or controlled-substance program that regulators, investigators, sites, and investors can trust?

• What will FDA, DEA, EMA, MHRA, Health Canada, or PMDA expect?

• How do we prepare for expedited programs, orphan designation, pediatric planning, or scientific advice?

• How do we translate approval strategy into REMS, site readiness, controlled distribution, patient access, and real-world delivery?

For inquiries, speaking invitations, advisory engagements, or fractional regulatory support:

LinkedIn | email: odettehauke@gmail.com