Safety of medical devices and topical medications

GAIKER leads the development of alternative methods for for assessing the safety of medical devices and drugs

At GAIKER, we are proud to offer advanced, ethical solutions regarding the safety of healthcare products and drugs. We carry out state-of-the-art in vitro and ex vivo studies to assess the safety of these products at various stages of their development, from pre-clinical to clinical phases. This approach allows us to detect potential risks early, thereby ensuring the safety and efficacy of products for the end consumer.

One of the cornerstones of our work is biocompatibility, which we assess without the need for animal testing. This approach not only helps minimise the use of animals in experimentation, but also contributes to the development of more ethical alternative methods, in line with the principles of the 3Rs (replacement, reduction and refinement).

We have state-of-the-art tools and equipment that enable us to provide a wide range of tests that are adapted to customer needs:

• Safety tests
• Cytotoxicity tests
• ADME-tox studies covered by a guarantee of good laboratory practices (GLPs)
  • Absorption
    • Skin absorption (OECD 428). Franz Diffusion Cells
  • Organ-specific toxicity
    • Organo-specific toxicity tests
  • Toxicity mechanisms
    • Tailor-made tests: apoptosis/necrosis, oxidative stress, inflammation, DNA damage, intracellular calcium, etc.
  • Genotoxicity
    • Ames test (OECD 471)
    • Mutagenicity in mammalian cells (OECD 476)
    • Micronucleus test (OECD 487)
  • Eye tests
    • Eye irritation and damage (OECD 492, Het-Cam)
  • Skin tests
    • Skin corrosion/irritation (OECD 431, OECD 435, OECD 439)
    • Phototoxicity (OECD 432)
    • Oral, nasal, vaginal and gingival irritation

More information – info@gaiker.es