The agentic CMC consultancy built for execution.

Built by regulatory consultants, for biotechs, to speed up time to IND submission.

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Built by a team from
Our Specialists

Our specialists

40+ years
of combined CMC and regulatory experience.
Sarmitha Sathiamoorthy

Sarmitha Sathiamoorthy, Ph.D.

  • 15+ years in biopharma CMC, from Sanofi Pasteur to advanced-therapy startups
  • Vaccines, immuno-oncology, cell & gene therapy and biologics
  • CMC, pre-clinical, manufacturing & release, regulatory writing and QMS, filing across FDA, Health Canada and EMA pathways
  • Published author on biologics analytical methods
Xiaoming Zhang

Xiaoming Zhang, Ph.D.

  • Former Roche CMC specialist, now an independent principal
  • 25+ years in CMC: small molecules, conjugated peptides, drug-conjugates and ADCs
  • IND-enabling through NDA, Module 3 drafting and submission strategy, US (FDA) and Europe (EMA)
  • CDMO selection and oversight; drug substance & product from clinical supply to commercial; inventor on 60 issued US patents
What we deliver

Higher quality CMC consulting at AI speed.

Spend your time and money on what matters - getting drugs to patients.

Regular CMC consulting
~4.5 months

Senior specialists rely exclusively on slow, manual workflows. Prone to human error.

Onyx CMC
~4 weeks

Senior specialists leverage AI efficiency and precision - and personally sign off on every deliverable.

Indicative figures based on average project lengths for historic Module 3 CMC work.

Questions

What to know before you call.

Cell and gene therapies are our lead: autologous and allogeneic cell products, AAV, LNP, and related advanced therapies. We take on small molecule, ADC and biologics CMC work where the team has a direct fit.
A mutual NDA is in place before any data moves. Your data is isolated between engagements, never shared across clients, and all access is fully auditable.
You do. You own all deliverables and the intellectual property in them.
Following a scoping call with a senior consultant to assess your needs, we'll provide a tailored package to speedrun your regulatory compliance work.

The FDA uses AI.Do you?

Talk to us about your CMC consulting needs, and let us handle the rest.

Book a scoping call