[ 00 ] PROJECTS
Real programs, moved forward under real pressure.
A selection of Fenix engagements across clinical, regulatory, funding, and manufacturing work. Details are anonymised to protect client confidentiality.
6 wkfrom kickoff to board-ready roadmapA pre-seed biotech had promising data but no clear path to the clinic, and investors wanted to see one.
THE CHALLENGE
Strong science, but no defined regulatory pathway, no view of preclinical requirements, and no credible timeline to show a board.
OUR APPROACH
Fenix ran a full gap analysis across regulatory, preclinical, and quality, then built a staged roadmap with decision points and costs attached.
THE RESULT
A board-ready roadmap that de-risked the programme and anchored the raise conversation in a defensible plan.
9 motox package delivered to IND standardA university spinout had compelling in vitro results and needed a preclinical package that regulators would accept.
THE CHALLENGE
Academic data that did not map to ICH expectations, and no in-house experience translating research into a regulatory package.
OUR APPROACH
Fenix scoped the ICH-aligned toxicology and PK/PD work, selected candidates on developability, and managed the studies through to report.
THE RESULT
A preclinical package that supported the IND without the repeat studies that so often follow academic-stage work.
11 mofrom engagement to first patient dosedA small biotech needed to take a novel oncology compound into its first paediatric trial without a clinical team of its own.
THE CHALLENGE
Strong preclinical data, but no in-house clinical operations and a paediatric population that regulators watch closely on dosing and consent.
OUR APPROACH
Fenix built the Phase I protocol, age-appropriate dosing plan, and family consent process, then ran HREC submissions, site selection, and monitoring end to end.
THE RESULT
First patient dosed on schedule, with a clean safety dataset and an ethics package that cleared without major revisions.
0validation failuresA biologics developer had to move from pilot batches to GMP supply without slipping its clinical timeline.
THE CHALLENGE
A process that worked at small scale, a new manufacturing partner, and no room in the schedule for a failed transfer.
OUR APPROACH
Fenix ran the tech transfer, validation, and vendor qualification, and aligned QA oversight and supply so clinical demand stayed covered.
THE RESULT
GMP material was released on time, and the first validation campaign passed without a repeat run.
4markets planned from a single core submissionA medical device company needed a submission strategy that worked across TGA, FDA, EMA, and MFDS at once.
THE CHALLENGE
Four agencies, four sets of expectations, and a small regulatory team trying to avoid running the same work four times.
OUR APPROACH
Fenix built a single core dossier with market-specific modules, sequenced the agency meetings, and managed responses through to decision.
THE RESULT
The device secured its first approval ahead of plan, with the remaining submissions reusing most of the core package.
1stlaunch sequence planned before approvalAn approved therapy risked stalling because launch planning had not kept pace with the regulatory work.
THE CHALLENGE
Approval secured, but no access strategy, no distribution route, and a brand that had never been tested against the standard of care.
OUR APPROACH
Fenix set the market sequence, pricing and access approach, built the distribution route, and shaped positioning and packaging for each market.
THE RESULT
A launch plan ready on approval, with distribution and post-registration support in place from day one.
[ 04 ] NEXT STEP
Need a partner who can sharpen the path and help carry it?
Bring us in when the next milestone matters, the pathway is complex, or the team needs deeper scientific and regulatory support.
