In the field of medicine and health care, biosafety specifically refers to proper handling of tissues or organs from biological origin, genetic therapy products, or viruses with respect to the environment, to ensure the safety of researchers, lab staff, health care workers, patients, and the general public. Biosafety testing is a series of assays to evaluate the potential biological risks of new compounds, including viral testing, microbial testing, cell and molecular testing, and analytic testing.
Health authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require all biopharmaceutical products to undergo strict biosafety testing to ensure the products are safe and free of contamination. Developing the most suitable test strategy for drug candidates which present new technologies or new concepts to regulatory authorities can be a big challenge. It requires a deep knowledge of pharmaceutical industrial to discover the potential risks that might exist and receive intense scrutiny by the regulatory agencies. At Creative Animodel, we will cooperate with you to identify a sound and cost-effective biosafety testing strategy and assist you in obtaining approval of your products from regulatory agencies.
Biosafety Testing Services at Creative Animodel
As a leading contract research organization in biopharmaceutical toxicology, Creative Animodel offers a broad range of biosafety testing services, including microbiology, cell biology, molecular biology, as well as analytical services. We can help you ensure the product safety and meet regulatory requirements. If you have any specific needs, please don’t hesitate to contact us.