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CLP

The new regulation 1272/08/EU

REACH

The regulation 1906/2006/EC

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Services

  • REACH
  • Enviroment Risk Assessment on pharmaceutical products
  • OELS determination and safety occupational classification
  • Toxicological Expertise
  • Single Study Monitoring
chemsafe

Testing Network

CHEMSAFE operates as a network and its objective is to present customers with the best option available in terms of Quality, Cost and time-effectiveness and satisfying all regulatory requirements.
Chemsafe is not a testing house but cooperates with a number of international laboratories (CROs) specialized in offering safety testing.

The three areas covered by these cooperation are:

  • Physico-chemical testing
    • large panel of studies to assess the hazard of the chemical studies
  • Toxicological testing including
    • general toxicology (short and long term exposure)
    • reproductive studies (teratology and development)
    • mutagenicity (in vivo and in vistro) and cancerogenicity testing
    • ADME Studies
    • dermal absorpion studiesw
  • Environmental testing
    • ecotoxicology (short and prolonged tests)
    • environmental fate studies
    • biodegradation and bioaccumulation studies

All laboratories act in compliance with Good Laboratories Practices (GLP), internal Quality Assurance (QAU) and archiving procedures.
OECD, EC, OPPTS and ISO test methods are followed in order to comply with different countries submission. The laboratories are medium sized and located all around Europe (Switzerland, Germany, Italy, France, Austria, UK and Spain) allowing Chemsafe to offer the best option to its customers.
Chemsafe specialized staff operates as Study Monitor of outsourced studies on behalf of customers. Timeframe control is part of the activity of the study monitor.
Our customer remains owner of the committed study as it appears as GLP study Sponsor in the related final report.


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