Preclinical toxicology and medical safety for pharmaceuticals and medical devices
What is this actually about?
This is about biocompatibility, i.e. the biological compatibility of medical devices and pharmaceutical products.
This means that a product used in medicine must not have any avoidable adverse effects on the patient or user… and this must be proven before it is used on humans. ISO 10993 is the guideline that describes the biological and medical criteria to be applied when testing the biocompatibility of medical devices. This includes a series of biological endpoints such as toxicity and immune compatibility as well as physical/chemical methods for the chemical characterisation of the products or the materials used and the raw, auxiliary and operating materials. Here, particular attention is paid to impurities, e.g. from the production process, as well as to substances that can be extracted and washed out of the materials.
Who we are
Pharm/Tox Concept was founded over 10 years ago to offer regulatory testing services for life science companies such as pharmaceutical and medical device manufacturers. Today we represent a competence network of doctors, scientists and technicians and are active in the exciting area of research and development of new products and work with small “start-ups” through to “global players”.
Dr. Thomas Becker
How we can support you
‘Pharm/Tox Concept’ offers high-quality and competent solutions for chemical and biological testing and product evaluation worldwide to support you in complying with the ISO 10993 series of standards in particular. This is done independently, scientifically, transparently and reliably in close coordination with the requirements of the authorities and our customers and in compliance with the applicable quality management systems.
In addition to the application of international standards, in particular the ISO 10993 series, our core competence lies in the creation of safety concepts (Biological Evaluation Plan (BER)), the evaluation of studies (Toxicological Risk Assessment (TRA)) and the final determination of biocompatibility (Biological Evaluation Report (BER)). We accompany your project from start to finish and ensure that resources are utilised efficiently and deadlines are met.
Solutions are our goal
Throughout the entire project, PhaToCon is your contact for all toxicological questions. Maximum legal certainty is an important component of our solutions; scientific competence and experience are at least equivalent. We work holistically, taking into account all available information, regulatory, scientific and technical.
Numbers that speak for themselves
> 0
conducted approval-relevant studies under GLP/GMP
1
Years of industrial experience in applied toxicology
456
Studies that were not accepted
These are our values
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