Medical Devices and Cosmetics

Assistance in Product Development

Assistance during the early phase of product development by screening toxicity profile of the ingredients and making necessary recommendations

Biological Safety Assessment

Upfront biological safety assessment on the product. This is performed by literature search and querying established toxicology databases. Reduces unnecessary testing and shortens the time to market.

Biocompatibility Tests

Conduct Biocompatibility tests on the finished products in line with ISO10993 guidelines to fulfill safety and regulatory requirements.



Biological Safety Assessment

Stage 1: Initial Biological Safety Assessment and Planning

This is based on a review of published literature and past experiences with the use of the ingredients. This step will identify whether or not the product is safe for marketing. If there are some data gaps, we will make recommendations for additional testing.

Stage 2: Outsource Additional Testing if Required

We project manage the additional testing required that our clients get a quality data on time and at a competitive price.

Stage 3: Final Biological Safety Assessment Report

We combine the outcomes from stages 1 and 2, and issue a Final Biological Safety Assessment Report. This will be signed by a Registered Toxicologist.



Advantages of Safety Assessment

  • Literature review upfront and identification of data gaps
  • Effective Toxicology planning
  • Avoid duplication of testing
  • Cost benefit by avoiding unnecessary testing
  • Time advantage by avoiding unnecessary testing
  • Quicker registration
  • Reduction of animal testing

Some of our peer reviewed publications in this area

  1. Garrigue JL, Ballantyne M, Kumaravel T, Lloyd M, Nohynek GJ, Kirkland D, Toutain H. In vitro genotoxicity of para-phenylenediamine and its N-monoacetyl or N,N'-diacetyl metabolites. Mutat Res. 2006 Sep 19;608(1):58-71.
  2. Dufour EK, Kumaravel T, Nohynek GJ, Kirkland D, Toutain H. Clastogenicity, photo-clastogenicity or pseudo-photo-clastogenicity: Genotoxic effects of zinc oxide in the dark, in pre-irradiated or simultaneously irradiated Chinese hamster ovary cells. Mutat Res. 2006 Sep 5;607(2):215-24.
  3. Kumaravel TS, Vilhar B, Faux SP, Jha AN. Comet Assay measurements: a perspective. DOI: 10.1007/s10565-007-9043-9. Cell Biol Toxicology 2007.
  4. The scientific committee on cosmetic products and non-food products intended for consumers . Opinion on Lawsone. COLIPA 2005.

OUR FOCUS



TESTING

  • High Quality, Cost Effective Testing
  • General, Genetic, in-vitro and Eco-toxicology
  • Mechanistic and Investigative Toxicology

CONSULTATIONS

  • Scientific and Regulatory Affairs
  • 3rd Party Study Monitoring


WHY GLR?


  • High Quality Standards
  • Cost Effectiveness
  • Regulatory and Scientific Consultations


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