EdGe Toxicology
Consulting.
EdGe Toxicology provides expert nonclinical consulting to help pharmaceutical and medical device manufacturers navigate the evolving regulatory landscape.
Scientific expertise. Regulatory insight. Real-world impact.
Expert team
EU- and US-certified toxicologists with decades of industry experience.
Strategic Approach
Collaborative nonclinical strategy & study design tailored to your needs.
Regulatory Excellence
High-quality regulatory writing and global submissions support.
Quality & Integrity
Rigorous, science-based approach to ensure safety and compliance.
What we do
A collaborative approach, from strategy to submission.
We work in close partnership, with your team, to define the testing strategy depending on your clinical intentions and targeted markets.
Pharmaceuticals / Biotechnology
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Medical
Devices
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Our Services
Nonclinical strategy & study design
Integrated development planning aligned to your clinical route.
Study monitoring & oversight
A single point of contact coordinating outsourced studies.
Regulatory writing
Nonclinical documentation for clinical trial and marketing submissions.
Biological evaluations
BEPs, BERs and biocompatibility for medical devices.
Toxicological risk assessments
TRAs according to ISO 10993-17 and ISO/TS 21726, equivalency and in silico QSAR assessments.
Impurity & excipient assessment
Per ICH Q3D, ICH Q3C and ICH M7.
Explore
A Trusted Partner
EdGe Toxicology brings extensive experience to support clients throughout product development, from early planning through to registration. This can involve targeted input at a specific stage, or a fully integrated development programme.
Our Consultancy
We partner closely with development teams to guide nonclinical programmes from first principles through to regulatory submission.
Our Expertise
EdGe Toxicology brings together senior toxicologists who have worked across CROs, small biotechs and large industry.
Our Work
We bring extensive experience delivering biological evaluations and toxicological risk assessments in accordance with applicable ISO standards and local regulations.
Credentials
ERT
European Registered Toxicologist
DABT
American Board of Toxicology
FRCPath
Toxicology