Cerberus guides biotech founders and R&D teams through the science-to-market pathway — regulatory strategy, clinical development, and IP positioning built on decades inside the agencies you're trying to convince.
Every biotech hits the same four chokepoints between a discovery and a product. We staff each one with people who've sat on the other side of the table.
Pre-IND and pre-submission planning, agency meeting prep, and designation strategy for FDA and EMA pathways — built by people who used to sit on the review side.
Trial design, endpoint selection, and CRO oversight built to hold up under statistical and regulatory scrutiny.
Freedom-to-operate review, patent strategy, and term sheet support for in-licensing and out-licensing deals.
Payer landscape, pricing strategy, and evidence generation planning aimed at reimbursement, not just approval.
We embed with your team for the length of the phase that matters, then step back. No standing retainers you don't need.
We audit your data package and current plan against the regulatory bar you're actually aiming for.
A written strategy with named milestones, agency touchpoints, and the studies that will and won't move the needle.
We sit in your working sessions, draft agency-facing documents, and pressure-test decisions before they're locked in.
Documentation and rationale live with your team, not in our heads, so the next phase doesn't need to start over.
A 30-minute call — we'll tell you honestly if there's a faster path.