NOTOX - Drug Development Services

NOTOX specializes in contract safety research and consultancy for the non-clinical development and registration of pharmaceutical products worldwide. More than 300 well-trained and dedicated specialists and 12,300m² of modern purpose built laboratories and offices are available to support you with regulatory toxicology, pharmacokinetics, metabolism, bioanalytical services and other safety research studies.

Our operations have been endorsed by the GLP Monitoring authorities and conform to the principles of OECD / EPA / FDA good laboratory practice and enjoy JMAFF certification. In addition to the headquarters in 's-Hertogenbosch, the Netherlands, NOTOX has support offices in Japan, Switzerland and the USA.

NOTOX was founded in 1983 and evolved as a privately held company until 2005. In this year, NOTOX became part of a worldwide group of autonomous companies (WIL Research, OH USA and QS Pharma, PA USA), providing toxicology research services. This trans-Atlantic presence was built with a vision to seamlessly address, the service needs of international industry partners.

Preclinical development toxicology

We offer a complete set of safety studies supporting your IND / CTA and NDA / MAA services, ranging from in vitro genetic and toxicity testing to full regulatory in vivo studies: acute to chronic toxicity, carcinogenicity, reproduction and developmental studies, safety pharmacology and immuno-toxicology.

Environmental risk assessment

Environmental risk assessment for pharmaceuticals (EMEA) is performed routinely, as we have conducted this kind of research for other industries for over 20 years. Studies are conducted in a wide variety of rodent and non-rodent animal species using all common routes of administration.

Analytical support, bioanalytical research, formulation analysis, biomakers and cytokine

Analytical support concerns formulation analysis, bioanalysis including biomarkers and cytokine analyses, metabolite profiling, and other chemical analyses covering all phases of pharmaceutical drug development, using the most modern technologies like UPLC-MS² and accurate mass MS (Orbitrap) for samples from both pre and clinical research.

Pharmacokinetics and metabolism

On top of the regulatory required studies, we offer many years of experience in dedicated personalized services to better profile your candidate drug. Our scientists design tailor-made studies using in vitro techniques (e.g. CYP450 inhibition / induction with fresh or cryo-preserved human hepatocytes) to understand ADME and interactions.

The application of sophisticated mass spectrometry or radiometry techniques with both in vitro and in vivo models enables elaborate drug / metabolite elucidation.

Non-clinical program consultancy

Our consultants, scientists and project managers use their knowledge and experience to design complete non-clinical programs for each new chemical or biological entity (NCE or NBE) from lead to phase I clinical trials, POC or phase III. For REACH, we have developed a ten-step program to compliance.

REACH

We have developed a ten-step program to compliance. Please contact us for the full program description.