Toxicology consulting is a specialized field that provides expertise in a number of areas including pharmaceutical, biotechnology, and medical device development; new excipient safety; product contamination assessment; occupational and environmental safety; and food safety. Toxicology consultants also work with attorneys in legal cases that involve drugs or medical devices.
Toxicology consulting requires knowledge and expertise in the basic biological sciences as well as more specialized fields such as toxicology, pharmacology, and toxicokinetics. A toxicology consultant may work with many individuals on a variety of tasks and in many environments. We have provided some examples of fields and projects in which a toxicology consultant might be engaged to further explain the work that a toxicology consultant might perform.
Pharmaceutical and biotechnology companies often employ toxicology consultants to help establish the safety of a product. Such work can include the following: design of safety programs; selection of contract research laboratories (CROs) for the conduct of toxicology and other nonclinical studies; working with CROs to assure that the testing is done correctly and accurately; and participation in the preparation, quality assurance, and/or review of study documents such as protocols and reports. Toxicology consultants also can assist in the preparation, quality assurance, and/or review of various regulatory documents necessary for approval by the U.S. Food and Drug Administration and other regulatory bodies around the world, as well as provide expert advice when questions of safety are raised by regulators.
Toxicology consultants may also be employed by pharmaceutical and biotechnology companies to determine the safety of impurities, degradants, and/or contaminants in products under development or marketed products, as well as the safety of new excipients.
Toxicology consultants may work in the medical field to ensure the safety of workers. Often employed by a hospital, they will oversee the operations of employees and make sure there are no chemical or biological hazards. By observing passage of everything from patients to waste, the consultant will determine if hospital employees are at risk of contamination or other hazards. Based on this information, the consultant will draft reports with recommendations for the hospital to improve their facilities .
Environmental and occupational toxicology consultants may work in a variety of industrial settings including pharmaceutical and chemical manufacturing. Occupation toxicology consultants can analyze the operations of employees and establish acceptable chemical/drug exposure limits, whereas environmental toxicology consultants can analyze the impact of chemicals and drugs on the environment.
Food companies may also hire toxicology consultants in a number of areas such as safety assessment of dietary supplements and additives. By designing proper studies and overseeing their execution, toxicology consultants can help to move a food product to market in a timely manner.
Attorneys (both plaintiff and defense) may also hire toxicology consultants to assist in product liability cases involving drugs or medical devices. Exposure to environmental drugs/chemicals is another area where attorneys may interact with toxicology consultants. The consultants develop factual evidence and advise on the scientific merits of the case. In some situations, their reports and recommendations can be instrumental in settling a case early; in others, they may be required to serve as an expert witness at trial.
Whether you're working on drug safety, biopharmaceutics, operations, or clinical pharmacokinetics, it is important to find the right consulting in toxicology. An expert can help your team to move forward with your project in a legally and ethically responsible manner.