ABOUT
Thirty-five years of asking the hard questions — so you don't have to ask them twice.
Sandi Schaible founded Bonded in Science on the conviction that life science companies deserve a scientific partner who brings the full weight of their expertise to every engagement — not a junior team and a senior signature.
The science always has to be right. There are no shortcuts when patient safety is the outcome."
Sandi Schaible
Founder, Bonded in Science
The story behind Bonded in Science
After more than three decades inside some of the most complex regulatory science environments in the industry — most recently as an executive leader at WuXi AppTec — Sandi Schaible made a deliberate choice: to bring that depth of expertise directly to the organizations that need it most, without the layers that so often stand between a client and the scientist who actually knows the answer.
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The name Bonded in Science isn't an accident. It reflects both the chemistry at the heart of this work and the kind of partnership Sandi believes consulting should be — built on precision, trust, and the right chemistry between people who take the science as seriously as you do.
Today, Bonded in Science serves medical device manufacturers, pharmaceutical companies, and CROs across the full spectrum of chemical characterization, biocompatibility, extractables & leachables, and regulatory strategy — with the same commitment to getting the science right that has defined Sandi's career from the beginning.
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MISSION
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"We exist because the work of keeping products safe deserves more than a checkbox. Bonded in Science brings 35 years of deep regulatory science directly to the companies that need it — without the overhead or the distance of a large institution."
VISION
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"A life science industry where regulatory science is treated as a strategic asset — not an afterthought. Where the chemistry is done right the first time, and the people responsible for patient safety have the expertise they need to do their best work."
HOW SANDI WORKS
The beliefs that show up in every engagement
These aren't values written for a website. They're the things that would feel wrong to leave out — because they shape every conversation, every deliverable, and every recommendation.
The science always has to be right — no shortcuts
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There is no version of this work where cutting corners is acceptable. When patient safety is the downstream outcome, the standard for scientific rigor isn't negotiable — it's the whole point. Sandi will tell you what the science actually says, even when it's not what you were hoping to hear.
Senior expertise, directly delivered
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At Bonded in Science, you work with Sandi — not a junior team with a senior review. That means the person who understands your challenge most deeply is the same person doing the work, writing the deliverable, and answering your questions.
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Bringing clarity to complexity
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The standards are dense. The regulatory landscape is evolving. The analytical data can be overwhelming. One of the most valuable things a senior scientific partner can do is translate all of that into language your team can act on — without losing the nuance that matters.
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Partnership over transaction
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The best consulting relationships aren't transactional — they're built on genuine understanding of your organization, your products, and your regulatory environment. Sandi invests in that understanding because it's what makes the work better.
MY STORY
Thirty-five years in the making
Sandi's career in regulatory science began with a BS in Chemistry from Winona State University and a fundamental conviction that the chemistry behind medical products matters — not as a compliance exercise, but as the foundation of patient safety.
Over the decades that followed, she built her expertise inside some of the most demanding scientific environments in the industry — developing deep technical fluency in chemical characterization, extractables & leachables, biocompatibility, and regulatory toxicology at a time when many of the frameworks now governing these disciplines were still being written.
"I've spent my career at the intersection of analytical chemistry and regulatory science — which means I understand both what the data says and what regulators need to hear. Those two things aren't always the same, and bridging that gap is where the real work happens."
Most recently, Sandi served as an executive leader at WuXi AppTec, overseeing Analytical Chemistry and Regulatory Toxicology across a global portfolio of life science clients. That experience — leading at scale, navigating complex regulatory environments, and building high-performing scientific teams — informs everything she brings to consulting clients today.
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As an active member of ISO TC194, the international committee responsible for the standards governing biological evaluation of medical devices, Sandi doesn't just interpret the standards — she contributes to shaping them. It's a perspective that very few consultants can offer, and it's one that consistently changes the quality of the conversations she has with clients.
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Bonded in Science exists because Sandi believes the best version of this expertise should be directly accessible — without institutional layers, without junior intermediaries, and without ever treating the science as secondary to the schedule or the budget.
CREDENTIALS & EXPERTISE
The experience behind every engagement
Education
BS in Chemistry, Winona State University. A foundation in analytical science that has informed three decades of applied regulatory chemistry work
ISO TC194 committee
Active expert member of ISO TC194 — the international committee responsible for standards governing biological evaluation of medical devices, including the ISO 10993 series.
Core technical areas
Chemical characterization (ISO 10993-18), extractables & leachables, biocompatibility (ISO 10993 series), regulatory toxicology, PFAS characterization, FDA submissions.
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Industry experience
35+ years in regulatory science — spanning lab bench, program leadership, and executive roles across CRO and life science environments.
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Executive Leadership
Former executive leader of Analytical Chemistry and Regulatory Toxicology — overseeing global programs for medical device and pharmaceutical clients at scale.
Speaking & education
Established speaker at industry conferences and corporate events. Founder of The Academy by Bonded in Science — expert-led regulatory science training for life science professionals.
ISO TC194 Expert
ISO 10993-18
ISO 10993-1
Extractables & Leachables
Chemical Characterization
Biocompatibiity
Regulatory Science
FDA Submissions
PFAS
Strategic Leadership
Chemistry
Beyond the work
Sandi believes that the best scientists are curious about everything — not just the problems in front of them. Outside of consulting, she is committed to raising the standard of regulatory science education through The Academy, contributing to the next generation of standards through ISO TC194 committee work, and speaking at industry events where the conversations that matter are still being had.
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She is based in Minnesota and works with clients across the United States and internationally.
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The Academy by Bonded in Science
Building a training platform that makes expert regulatory science education accessible to professionals at every level — from lab technicians to executives.
ISO TC194 standards development
Active committee work contributing to the international standards that govern how the industry approaches biological evaluation and chemical characterization.
Industry speaking
Regular speaker at conferences, association events, and corporate webinars — bringing the same direct, expert perspective to audiences across the life science industry.