The expertise your organization needs — without the constraints of a large institution.
Deep regulatory science, strategic clarity, and senior-level partnership — brought directly to the teams building life science products that protect patients.
CONSULTING SERVICES
WHO WE SERVE
Built for the organizations where the science has to be right
Bonded in Science works with companies across the life science product development ecosystem — from early-stage device startups navigating their first biocompatibility program to established pharmaceutical firms managing complex regulatory submissions.
Medical device manufacturers
Biocompatibility programs, ISO 10993 strategy, chemical characterization, extractables & leachables, and submission support
Pharmaceutical companies
Container closure system evaluations, chemical characterization, and regulatory strategy for drug product and combination product submissions.
Testing Labs
Fractional scientific leadership, program development, team building, and expert guidance for organizations scaling their regulatory science capabilities.
AREAS OF EXPERTISE
35 years of specialized knowledge — applied to your most complex challenges
Biocompatibility & ISO 10993
Strategy development, gap assessments, and expert review of existing programs through the eyes of a chemist. Deep familiarity with the evolving ISO 10993 series as an active TC194 committee expert.
Extractables & Leachables
End-to-end E&L program design, oversight and/or support — from study design and analytical method selection through risk assessment and regulatory submission. Both pharmaceutical and medical device contexts.
Fractional Scientific Leadership and Strategy
Senior-level regulatory science leadership on a fractional basis — ideal for growing organizations that need CRO-level expertise without the overhead or existing laboratories ready to take it to the next level. Includes team building, program development, and strategic planning for regulatory science functions.
HOW WE WORK TOGETHER
Three ways to engage — built around what you actually need
Every engagement is scoped to fit your organization's timeline, budget, and the complexity of the work.
Retainer
A dedicated monthly partnership for organizations with ongoing or evolving regulatory science needs. You get prioritized access, deep organizational understanding, and strategic continuity across projects.
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Ideal for: long-term strategic support.
Project Based
A defined scope with clear deliverables and a flat fee. Work begins with an alignment session, proceeds through structured milestones, and ends with a final deliverable — no surprises.
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Ideal for: Projects with a clearly defined scope and timeline.
Hourly Rate
Ad hoc expert access for data review, regulatory Q&A, second opinions, or exploratory conversations. Transparent billing, no commitment, and no minimum engagement required.
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Ideal for: small projects, quick questions or reviews
RETAINER PARTNERSHIPS
Ongoing chemical characterization program support — built on standards, not guesswork
Chemical characterization is not a one-time event. It's a living program that requires deep knowledge of evolving standards, analytical methodology, and how chemistry integrates into the broader biocompatibility picture. This is the work a retainer was made for.
For testing laboratories
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Expert scientific oversight for your chemical characterization programs — from study design and analytical method selection through data interpretation, risk assessment, and regulatory reporting. A senior partner who understands the standards as well as the bench.
For device & pharma companies
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Strategic guidance on how chemistry integrates into your biocompatibility program — so your characterization data tells the right story to regulators. Bridging the gap between analytical results and defensible biological evaluation conclusions.
1. Discovery Call
A focused conversation about your chemical characterization program — where it stands, where the gaps are, and what ongoing scientific support would look like in practice.
2. Retainer Scope and Agreement
We define your monthly hours, program priorities, and engagement terms — clearly written so both sides know exactly what the partnership covers.
3. Ongoing Program Support
A structured kickoff followed by regular cadence — reviews, guidance, and strategic input that keeps your program aligned with current standards and evolving regulatory expectations.
4. Continous Partnership
Your retainer renews monthly with the flexibility to scale as your program needs change. When standards shift or new questions arise, you have a partner who already knows your work.
Why chemical characterization demands a long-term scientific partner
The standards governing chemical characterization — ISO 10993-18, ISO 10993-17, and the broader biocompatibility framework — are not static. They evolve, and the expectation of how chemistry integrates into biological evaluation continues to increase in complexity. A retainer means you have a partner who:
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Stays current with ISO TC194 standards development — including what's coming, not just what's published
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Can translate analytical chemistry data into biocompatibility conclusions regulators accept
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Is available when you need a fast answer — not just when a project is formally scoped
CLIENT RESULTS
What working together looks like in practice
"The right scientific partner doesn't just answer your questions — they help you ask better ones."
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Client case study results coming soon.
"I just wanted to express a big THANK YOU for you being here and supporting our Medical team."
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MEDICAL DEVICE CUSTOMER
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"The content was fantastic and the feedback positive all around. You hit the right level of detail and the analogies were well received. The team walked away with a better understanding and more importantly, alignment, on how we can serve the market."
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CRO/TESTING LAB
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Your science deserves the right partner.
Let's talk about what that looks like for your organization