Bioassay

We are a trusted provider of development, validation and routine bioanalytical assays for global players and start-up companies in the pharmaceutical, chemical, and cosmetic industries. Our services are performed under GMP and GLP certification to meet regulatory guidance for pre-market and on-market products. We develop and execute potency assays for biologics, proteins, and active pharmaceutical ingredients under established quality guidelines. Our FDA-inspected laboratories and highly qualified staff provide an excellent framework to carry out GMP & GLP certified analytical services and allows us to deliver successful projects and routine bioanalysis. Over the years we have developed a range of customized, product specific, potency assays in accordance with US Food & Drug Administration (FDA) and the European Medical Agency (EMA) standards, as well as guidelines issued by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). We also have extensive experience working with biosimilars or modified biologics, such as pegylated products. We support the development and manufacture of pharmaceuticals, biopharmaceuticals, and specialized healthcare products. Discover our standardized safety assay formats for chemical and cosmetic products.