Your CMC and manufacturing division, on demand.
CONSULTING
Senior operators embedded in your program. We plug in as your CMC division, set regulatory strategy, direct tech transfers, and move a program from compound selection to first-in-human across every major modality.
Status: Available now. This is the work we do every day.
35+ yrs
Combined biomanufacturing leadership
Pharma, Biotech and CDMOs
Where our team built and scaled
Global
FDA, EMA, MHRA and beyond
THE PROBLEM
Most programs do not need a department. They need the right operator.
Building an internal CMC function is slow and expensive, and a generalist consultant will not carry a program through a tech transfer or an agency meeting. What a program needs is someone who has done the work before, available at the point the decision is being made.
MODALITIES
Every major modality.
mRNA and RNA, antisense oligonucleotides, lipid nanoparticles, gene editors, viral vectors, cell therapies, and vaccines. From established biologics to the newest personalized medicines.
WHAT WE COVER
End to end, or exactly where you need us.
CMC strategy and process development
A development plan built for your molecule, your timeline, and your budget.
Regulatory strategy, global reach
Agency strategy and submissions, including multi-agency paths where they buy speed.
Tech transfer and scale-up
Clinical to commercial transfers directed by people who have run them.
Manufacturing and CDMO oversight
We source, qualify, and manage external partners as your accountable owner.
HOW WE ENGAGE
We move fast and we get things done.
We often engage about a month before final compound selection and act as an outsourced, plug-and-play CMC division. Engagements range from targeted project work to full program ownership, structured to your stage and budget. We are selective about the programs we take, and we treat your timeline as our own.
Tell us about your program.
We will tell you how to get it to patients faster.