toXcel International
About us
toXcel International Ltd are Scientific and Regulatory Consultants providing support to clients requiring toxicology and regulatory support in the UK, Europe and North America. Experienced staff can provide data gap analysis, regulatory strategy, laboratory selection, study design, CRO audits , study monitoring and report review.
Our Life Sciences team supports our clients in compliance with U.S. and international regulation of pesticide, pharmaceutical, cosmetic, and chemical products and devices. Our main areas of focus are US EPA (FIFRA and TSCA), US FDA, UK and EU REACH, Cosmetics Regulation, CLP, and state regulations including California DPR and Proposition 65.
Toxicology Expertise
Understanding and communicating the health and safety risks of chemicals, pesticides, and pharmaceutical products is critical to gaining regulatory approval and protecting public health. At toXcel, our board-certified toxicologists (DABTs and ERTs) provide expert guidance to support your regulatory strategy with sound, science-based toxicological evaluations. We assist chemical manufacturers, formulators, pharmaceutical companies, personal care/consumer product manufacturers and suppliers, trade associations, law firms, and the food industry.
Toxicology Consulting for Regulatory Submissions: Leverage decades of experience from former senior government scientific and regulatory reviewers and managers and industry regulatory leaders to support your chemical, pesticide, and nonclinical drug development programs.
Hazard Identification & Risk Characterization: Evaluate existing toxicity data, design targeted studies, conduct literature reviews, and apply weight-of-evidence approaches to define the toxicological profile of your substance.
Expertise in Key Toxicology Disciplines:
Nonclinical Safety Studies conducted to OECD and ICH guidelines
Developmental and Reproductive Toxicology (DART)
Ocular Toxicology
Dermal Toxicology
Inhalation Toxicology
Neurotoxicology
Genotoxicity
Carcinogenicity
In-vitro testing and New Approach Methodologies (NAMs)
We deliver strategic toxicology support tailored to your product and regulatory goals.
European Cosmetics Regulation
To legally place a cosmetic product on the EU market, companies must comply with the European Cosmetic Products Regulation (EC) No. 1223/2009, which mandates a Cosmetic Product Safety Report (CPSR) as a core requirement. toXcel International helps companies meet these obligations by preparing scientifically robust CPSRs that ensure regulatory compliance and consumer safety.
The safety of a cosmetic is assessed based on the known properties of its ingredients. toXcel provides literature-based hazard assessments and reviews suppliers specifications and data, taking into account any impurities. Our overall assessment is based on the properties of the product and anticipated human exposure. The stability, microbial quality, packaging, and labelling are also taken into consideration. The report must be signed by a suitably qualified person; toXcel scientists include Registered Toxicologists (DABT, ERT) and Chartered Biologists (CBiol).
With hundreds of successful CPSRs completed, toXcel provides reliable, efficient support to help your cosmetic products gain and maintain market access in the European Union.