Process · Proof · Quality + Diligence

From Bench Science to Scalable, Audit-Ready Processes.

I help early-stage biotech companies, and the investors and acquirers evaluating them, turn bench-stage science into scalable, well-characterized, audit-ready processes, and give them a straight technical read on a deal.

Who I Help

Building it, funding it, or acquiring it. The same straight technical read.

Founders

Early-stage biotech, pre-seed to about Series B, across therapeutics, alt-protein, synbio, devices, and more.

Investors

VCs, PE, and family offices backing a biotech company who need a clear read on the science and team.

Acquirers

Strategics and corp-dev teams acquiring a bioprocess asset who want an independent read before they close.

What I Do

Four pillars, from bench to deal.

Process

Bench-to-Clinical Bioprocess

Development, scale-up, and tech transfer that hold up at GMP and on CDMO handoff.

Proof

Characterization & Preclinical

Characterization in vitro, ex vivo, and in vivo, plus preclinical testing (ISO 10993, via CRO).

Quality

Right-Sized QMS / ISO 13485

A quality system right-sized to your regulatory pathway. Audit-ready, without the bureaucracy.

Diligence

Technical & CMC Due-Diligence

A straight technical read on a target's process, data, and team.

Why It Matters

Get the fundamentals right early and everything downstream gets easier: cleaner scale-up, a smoother CDMO handoff, characterization that holds up, and diligence you can walk into with confidence. That is what well-structured, well-proven early-stage work makes possible, and it is what I help you build.

Monique de Leeuw, Principal Consultant

Why Me

12+ years taking recombinant-protein platforms from early-stage R&D to GMP clinical manufacturing.

I have built these processes from the bench up and learned firsthand where they break. I bring those hard-won lessons so you can skip the costly detours and get it right the first time.

  • Built an ISO 13485 quality system from scratch.
  • Deep process development, scale-up, and tech transfer.
  • Characterization and preclinical programs (ISO 10993) with CROs and universities.
  • Led technical diligence in a successful acquisition.
  • Named inventor on five U.S. patents.

MS Biochemical Engineering, TU Delft.

12+
Years, bench to GMP
5
U.S. patents
ISO 13485
Quality system from scratch
1
Acquisition, diligence lead

How I Engage

Flexible engagements, sized to the decision in front of you.

ProjectFixed-fee or hourly.
RetainerOngoing advisory, monthly.
Fractional2–3 days per week, embedded.
Diligence Sprint1–2 weeks, decision-ready.
Engagement standards. I decline conflicts of interest, and I never use or disclose confidential information. Discretion is built into every engagement.

Net-30. Engagement formats and rates on request.

Start a Conversation

Let's build something that lasts.

Tell me about your process, your program, or the asset you're evaluating. I'll tell you straight what the data supports and where the risks are.