We offer a full range of product development services that can be tailored to customer needs, covering all aspects of regulatory study requirements, including quality, safety and efficacy. In particular, we specialize in the design of studies to satisfy the requirements of the various authorities in Europe, the United States and Japan. Contemporary regulation puts greater responsibility on the industry to manage the risks from chemicals, so it is more important than ever to partner with an experience, expert CRO.
Charles River has extensive global capacity for all of our clients’ rodent and reproductive toxicity testing needs. Our experience includes the accumulation of comprehensive background data, which is particularly relevant for supporting carcinogenicity and reproductive toxicology. Our team of DART toxicologists is the largest in the industry, with vast experience in the design and conduct of reproductive toxicity studies to support international product registrations.
Toxicology Products & Services
Our genetic toxicology studies typically follow a tiered approach, beginning with an in vitro (bacterial) Ames test and progressing to short-term in vitro assays using mammalian tissues. We offer a range of studies to include these as well as additional in vitro assays and alternative strategies such as the in vitro BlueScreen HC™ assay.
Genetic Toxicology Products & Services
Charles River uses environmentally controlled incubation rooms to conduct the in-life phases of environmental fate studies. Test systems are available from a wide variety of geographical locations globally. All are fully characterized and confirmed as viable before the start of the study. We also offer a comprehensive range of environmental testing services, with specific expertise in handling volatile, complex, unstable, or poorly soluble compounds.
Environmental Fate Products & Services
The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (EC) No 1907/2006 addresses the production and use of chemical substances, and their potential impact on both human health and the environment. Implemented on 1 June, 2007, the mandate created a single regulatory system for both existing and new chemicals in Europe.
REACH demands a new level of precision in the analysis and characterization of the chemical composition of the substances. Often, companies lack the resources or expertise to produce and/or evaluate the required data.
Nearing half a century in serving the needs of the chemical industry, the Charles River team is prepared to assist clients with meeting REACH requirements quickly and thoroughly, ensuring no time is wasted on the way to market.
REACH Products & Services
Understanding the ever-evolving regulatory environment for industrial chemical products is essential to success. Charles River offers a thorough understanding of the regulations, plus the scientific expertise needed for compliance, to avoid unnecessary delays in the approval of your active substance or product. Our extensive experience with worldwide regulations, including those for the EU, EPA, JMAFF, and OECD, means you will be fully supported, regardless of where you wish to register your product.
Regulatory Support Products & Services