ChemRisk^® professionals are uniquely positioned to offer strategic and scientific expertise to pharmaceutical and medical device manufacturers dealing with questions concerning labeling and human health risk assessment aspects of product safety. Because of our extensive experience in conducting risk/benefit analysis and with the current regulatory emphasis on new products, we are also well qualified to assist clients in developing properly focused worldwide regulatory applications. We can also provide product-specific assistance at critical points during the discovery, safety assessment, manufacturing and control study, efficacy assessment, and environmental assessment phases of bringing a drug to market. At any point along the continuum, from preclinical research to post-marketing studies, our team of pharmacologists, certified toxicologists, practicing physicians and epidemiologists can help evaluate potential risks posed by any pharmaceutical agent to consumers.

Scientists at ChemRisk^® also have experience understanding and quantifying health risks associated with the use of medical devices. We can help manufacturers determine appropriate classifications for their devices, and identify important safety, efficacy, and risk/benefit issues. We also can assist clients in establishing compliance systems for post-market reporting, developing and maintaining device registries, and managing regulatory and public issues in the face of recalls. We also specialize in recognizing and characterizing the risks posed by chemical components of devices that may degrade or be released over time.

In summary, our staff has many years of professional experience evaluating the possible hazards posed by chemicals. Thus, we are ideally prepared to anticipate what regulatory agencies, the legal system, and members of the public will expect of manufacturers and sellers of pharmaceutical agents and medical device products.

Some of our relevant experience in this area includes:

• determining whether exposure to natural rubber allergens in latex gloves could be responsible for outbreaks of dermatitis in health care professionals;
• assessing risks from inhaling metal particles released by a medical device;
• assessing phthalate exposure due to release from the tubing of certain fluid delivery pumps; and
• evaluating the safety of silicone breast implants (SBI)