Life science and human health

Guarding public health

Products related to life science and human health are regulated by specific standards at all stages of their life cycle. We have the requisite expertise in the health and environmental aspects of the development, manufacturing, registration and marketing of these products. Our services cover the following four areas:

FOOD AND FEED SAFETY

As a manufacturer and distributor, it’s your responsibility to ensure and document food and feed safety.
To keep you compliant with the relevant regulations, we can:

  • provide documented safety assessments (also for food contact materials, dietary supplements and so on)
  • compile dossiers for submission to competent authorities
  • suggest limit values to critical control points in Hazard Analysis & Critical Control Points (HACCP)
  • take into consideration all sources of contamination, including your water resources

COSMETICS AND CONSUMER PRODUCTS

Placing cosmetics and other consumer products on the market requires the producer to ensure and document product safety in accordance with strict legal requirements. We have the necessary toxicological expertise and knowledge of regulations to support you. Our solutions include:

  • provision of a documented Product Information File (PIF) and preparation of cosmetic dossiers
  • labelling and notification of products to relevant authorities (including the EU Cosmetic Products Notification Portal – CPNP)
  • safety assessment and regulatory support of toys, textiles and other articles

MEDICAL DEVICES

Getting medical devices on the market is a lengthy process and being faster to market is crucial. Our solutions support the efficient development, registration and marketing of effective and safe medical devices. We can assist you with:

  • selecting and documenting biocompatible materials to ensure your development of safe products
  • data searches and identification of data gaps
  • complying with legislations
  • developing products with a minimal use of animal studies

PHARMACEUTICALS

Time is money. This is even truer in the pharmaceutical industry. You can accelerate your time to market by optimising the pharmaceutical development process or securing all the requisites needed to apply for marketing authorisation. We have the solutions for you, including:

  • toxicological expert consultancy in the pre-clinical phase
  • developing products with a minimal use of animal studies and maximum output of existing data
  • ecotoxicological tests recommended by the European Medicines Agency and GLP-compliant studies
  • testing strategies (including contact to Contract Research Organisations and study monitoring)