About Us

Experienced, pragmatic toxicology support.

Expert nonclinical consulting to advance pharmaceutical and medical device innovation.

Our Practice

Independent expertise, built over decades.

EdGe Toxicology experts have worked across CROs, small biotechs and large industry. We have successfully participated in regulatory submissions and approvals for a diverse range of products and across various jurisdictions.

Our Team

Over 35 years combined experience.

EdGe Toxicology brings together extensive experience across pharmaceuticals, biologics, medical devices and other regulated sectors. With complementary backgrounds, Simon and Valériane combine deep scientific expertise with a practical understanding of regulatory requirements. Their work covers everything from study strategy and oversight to biological evaluations, toxicological risk assessments and regulatory documentation.

Together, they provide experienced, pragmatic toxicology support across every stage of product development.

Simon Craige

director · Toxicology Consultant

Simon is a toxicology consultant with over 20 years in the industry, covering small molecules, vaccines, biologics and medical devices. He has worked across a diverse range of therapeutic areas (examples include oncology, CNS, ocular and dermal) and across all phases of drug discovery and development.

Having started in reproductive toxicology at a UK CRO, his career has taken him across numerous toxicological disciplines, into small biotechs, large industry and back into CROs, before forming EdGe Toxicology as an independent consultant in 2020.

His broad experience means he is adept at the project toxicology aspects of a programme — from CRO selection, study monitoring and protocol and report review through to regulatory document writing. On the medical device side, he has many years' experience delivering Biological Evaluations and Toxicological Risk Assessments.

ERT · 2012

DABT · 2014

FRCPath · Toxicology, 2025

BTS

ETS

SOT

ACT

Valériane Levelut

Toxicology Consultant

Valériane is a toxicology consultant with 15 years of experience across regulated sectors including medical devices, pharmaceuticals, cosmetics and food supplements. She holds a Doctor of Pharmacy and a Master's in Toxicology from Paris Descartes University.

Before joining EdGe Toxicology, Valériane provided consultancy services within several Contract Research Organisations, managing safety assessments for a wide range of products. Within the medical device discipline, she has successfully participated in CE marking and FDA approvals, and has authored more than 200 Biological Evaluations and Toxicological Risk Assessments.

She is recognised for her contributions to scientific communication, having spoken at international conferences and authored research across toxicology.

ERT · 2019

DABT · 2021

PharmD

MSc Toxicology

SFT

SOT