Toxicological Risk Assessment
Extractables &
Leachables
Biocompatibility Risk, Plan, and Reports
Chemistry,
Manufacturing,
& Controls Changes
Root Cause Investigation
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Science-Led
MedTech Solutions

The only global consulting firm merging scientific disciplines to solve complex challenges for your products — from early ideation and development to post-market support.
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About Us
Biocompatibility
ISO 10993-1
ISO 10993-17 & 18
345+ BEP, TRA, and BER
Trusted Partner
USP <1664>
USP <1663>
USP <1661>
Materials Selection
Toxicology
Chemistry, Manufacturing, and Controls (CMC)
As a specialized MedTech consulting firm, we enable companies with materials, chemistry, and preclinical strategies. With over 500 projects in our experience.
Our experienced team assists with developing biological evaluation plan (BEP), design extractable/leachable studies, review protocols, screen contract research organization (CROs), represent you in meetings with regulatory agencies and CROs, review protocols, prepare toxicological risk assessments, and assemble a biological evaluation report (BER) — all with a focus on speed, quality, and transparency.
Biocompatibility
ISO 10993
Toxicology
 Expertise 20+ Years
Trusted Partner
Certified
Fast Turnaround
305
+
Toxicological Risk Evaluation.
Expertise You Can Trust. With Our Unparalleled Expertise in Analogue Selections per ISO 10993-17:2023, We Saved Many Projects.
210
+
Biocompatibility Plan & Report
Solving Complex Problems and Delivering Tailored Solutions
142
+
Trained.
Educating Medical Device Innovators in Biocompatibility and Chemical Characterization
7
Technical Committees.
Shaping the Future of ISO 10993 Standards as Industry Experts
The Smarter Path to Regulatory Success
Others  vs. Chemva®
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Other Service Providers
Chemva®
Team Structure
Siloed experts working separately
Unified scientific team merging sciences for integrated consulting
Process
Redundant meetings; conflict of intertest with their internal labs; Repeat testing
Integrated approach with our clients from day one
Outcomes
Delays, upselling unnecessary tests, frustration, deficient submissions
Our clients' partner before labs, multi-approach strategies, clear submissions
Strategy
Reactive and fragmented
Purpose-driven and streamlined
Chemistry
Materials Science
Toxicology & Biocomptability
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Expertise in Action
Innovative Pathways from Concept to Compliance
Just like the many products we’ve helped secure preclinical approval for clinical studies or pre-market, we guide your product from concept to market, ensuring innovation, quality, and patient safety every step of the way.
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Expertise in Action
Trusted Delivery, Tangible Results
From precise testing to comprehensive digital reports, Chemva ensures every outcome is clear, reliable, and ready for regulatory submission. Our delivery means more than speed — it means confidence in every result.
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Expertise in Action
Proven Partnership, Lasting Impact
Our clients count on Chemva to solve complex challenges. See how our science-driven solutions lead to safer products, faster approvals, and lasting trust.
With You Every Step of the Way
Trusted by 85+ MedTech Innovators
Chemva delivers expert solutions, whether you need full-cycle support or help at a critical step.
Step 1
Product
Development
Step 2
Manufacturing
Support
Step 3
Preclinical
Biocompatibility
Step 4
Extractables/Leachables
(E&L)
Step 5
Post-Market Support
Why Chemva?
Because we care about your success as much as you do.
Here’s what makes us different.
CHEMVA
98
%
Client Retention Rate. Our clients don’t just come to us once — they come back. Trust, precision, and clarity are why.
Kinza F.
Business Devellopment Managet
Strategic Testing Support
Expert Support for
Certified Testing
While we are not a lab, we are our clients' defenders.
We guide and support all aspects of product testing — from selecting qualified labs to reviewing biocompatibility, E&L, and toxicology data aligned with ISO 10993 and FDA expectations. We strive for you, so labs do not upsell unneccsary tests or you do not repeat testing.
CHEMVA
Global-Ready Preclinical Strategies
We develop tailored testing strategies and review E&L and biocompatibility protocols to ensure your submission meets the expectations of global agencies, including FDA, NBs, Health Canada, MHRA, NMPA, TGA, HSA, and more.
Your Global Scientific Partner
Trusted by Companies Across 15+ Countries
We craft customized preclinical strategies to help companies overcome complex biocompatibility challenges. At Chemva, our integrated scientific disciplines enable us to deliver globally unmatched consulting services. Our materials selection process, for instance, carefully evaluates potential biocompatibility issues and leachables challenges.
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CHEMVA
Proven Results
Real-World Insights From Complex Projects
Learn about our scientific approach that helps clients.
Biocompatibility
Biological Evaluation Plan (BEP) for a Next-Generation Implantable Device
Developed a risk-based BEP to meet FDA and ISO 10993-1 standards, helping the client avoid delays and save $300K through targeted testing.
Biocompatibility
Medical Devices; Combination Products; Drug Products
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Details
Biocompatibility
Connectors Cracking: A Root Cause Analysis and Material Selection Effort
Chemva’s systematic approach not only resolved the cracking issue but also enhanced the product’s long-term reliability and manufacturability.
Materials, Failure Analysis & CAPA
Medical Devices; Combination Products; Drug Products, Personal Care Products
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Details
View all case studies
Testimonials
Leading Companies Trust Chemva to Navigate Complexity and Deliver Results
Sdip
M. Parviz, MSc, Ph.D.

Co-founder and CEO

“Chemva’s deep expertise in chemistry, materials science, and toxicology has been invaluable in supporting our projects at SDIP Innovations. Their team’s professionalism, thoroughness, and ability to meet deadlines have made a significant impact. Collaborating with Chemva has been seamless, and the insights provided have been critical to our success.”

New South Wales, Australia
Breas
K. Stenback

R&D Director

“Working with Chemva on evaluating the biocompatibility of a Breas device felt like having an extension of our team. Chemva was very flexible and provided help with very short notice.

They honoured every commitment, from tight deadlines to budgets, and provided consistent support throughout. I trust Chemva’s unparalleled expertise in chemistry, materials science, and toxicology makes them a strategic partner for any MedTech company project.”

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Mölnlycke, Sweden
Institut katharos
J. Vacca

Founder

“Chemva proved to be a true collaborator on evaluating the biological safety of our beauty products, listening to our needs and recommending practical approaches that were key to our success. We’d happily work with again.”

Aix-en-Provence, France
Iota
S. Datta, Ph.D.

Principle Materials Scientist

"Chemva material experts conducted thorough and comprehensive material risk assessments (MRA) to evaluate the biological safety of our implantable devices by integrating chemistry, materials science, and toxicology principles. Their expertise has been instrumental in addressing regulatory comments and ensuring smooth device submissions. Chemva is a highly valuable partner for any project in the medical device space."

Alameda, California, USA
Consulting. Collaborating. Catalyzing