NOTOX provides high quality support in the development of pharmaceuticals. Our regulatory services are aimed at assisting you in the design of tailor-made, efficient and time-saving non-clinical development programs.

To ensure that we provide you with high quality solutions for your needs, we work in close collaboration with our toxicology (in vivo and in vitro), in vitro metabolism, safety pharmacology and chemistry scientists.

Our services include consultancy, regulatory documents, in silico analysis, program management and environmental risk assessments.

Consultancy
Experienced regulatory affairs managers give you guidance on the non-clinical development program with your compound and give advice on study designs. In addition, reviews of the available data with your compound are performed including a gap analysis.

Regulatory documents
We prepare or review non-clinical sections of regulatory documents such as Investigator’s Brochures and non-clinical documents of the Common Technical Document.

In silico analyis
NOTOX has ample experience in in silico analysis using DEREK. DEREK is an expert knowledge base system that predicts whether a chemical is toxic in humans, other mammals and bacteria. The application provides a high throughput screen for several toxicological endpoints, including mutagenicity, carcinogenicity and skin sensitization.

Program management
Quality and progress of a program strongly depend on the quality and efficiency of the communication. For programs performed at NOTOX comprising various studies with a compound, we assign a program manager who will have regular contact with the monitor of the project at your company. Our program manager is one of our senior regulatory affairs managers or scientists, experienced in managing multidisciplinary projects. This will ensure, besides a timely completion, a thorough scientific management of the program with your compound.

Environmental risk assessment (ERA)
We have experienced ecotoxicologists and environmental chemists who prepare full environmental risk assessments for pharmaceuticals and veterinary products (following EMEA guidance).

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Environmental Risk Assessment of Pharmaceuticals (flyer)

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