PRODUCT SAFETY

Product Safety Assessment

Consumer Products

Dr. Parent has evaluated numerous consumer products prior to their introduction to the US and European markets. His letter of safety approval is honored in the EEC since he is a registered expert in Europe and France. He has evaluated cosmetics, hairsprays, body lotions, nail polish, household products, toys, ink formulations, “cosmeceuticals”, dietary supplements, and OTC drug formulations. Many of these product safety evaluations did not involve banned or expensive animal testing. On many occasions, an evaluation of existing information from suppliers, company files, trade organizations, and the open literature provides sufficient information to form an expert opinion on the safety of the product. Dr. Parent can provide a safety assessment of your product including possible risks related to its use or misuse.

• Accumulation of available data from on-line data bases, suppliers, company files, trade organizations, and the open literature.
• Critical evaluation of available data in the context of use patterns for your product.
• Development of approaches to determine exposure route (oral, dermal, inhalation) and dose under conditions of normal use and misuse.
• If required, protocol design, study placement, monitoring, and interpretation of animal or human studies on your product.
• Production of an “expert report” on your product signed by Dr. Parent, who is certified by both the American Board of Toxicology (ABT) and the Academy of Toxicological Sciences (FATS), and who is a recognized expert in the EEC(ERT).

Pesticides

Dr. Parent has designed protocol, placed, completed, interpreted, and submitted to the US EPA many toxicological studies in support of pesticide registrations, including in-vitro mutagenicity, acute and sub-acute toxicity studies, reproduction and teratology studies, neurotoxicity, chronic and oncogenicity studies in several species and by oral, dermal, intravenous, and inhalation routes. Dr. Parent is familiar with the capabilities of individual contract laboratories, therefore, assuring appropriate study placement.

• Protocol design in accordance with international (ICH) guidelines.
• Placement of studies at CROs throughout the world depending on client needs and the expertise which exists within the specific laboratory.
• Monitoring of studies, assisting in their interpretation and insuring accurate reports which reflect the data gathered from the studies.
• Preparation of submissions to the appropriate regulatory body.
• Presentation and defense of studies before the US EPA, European Union, or other appropriate body.

Pharmaceuticals

Consultox, through the services of Dr. Parent and others, has extensive experience in the design and placement of pre-clinical studies in the United States, Europe, and Japan. Although Dr. Parent focuses on the preclinical and clinical experimentation and technical reporting involved in the drug development process, he collaborates with colleagues to provide the client with support for the entire drug registration process from inception, including experimentation, reporting, quality assurance, IND/NDA preparation, and the remainder of the registration process including FDA interfaces.

Dr. Parent is certified in regulatory affairs by the Regulatory Affairs Professional Society. As a result of his expertise and that of his colleagues, Consultox can offer clients a broad array of regulatory consulting services, including the strategic regulatory planning for the development, preparation, and submission of INDs, NDAs, 510(k) submissions and qualifications of impurities in new drug substances in accordance with Q3A or Q3C ICH guidance. A wide range of regulatory audit activities is available. Consultox can undertake cGMP assessments of drug product manufacturing facilities or audit clinical trial facilities to assure compliance with applicable guidelines.

Other available regulatory services are the development of drug master files, service as a regulatory agent for our foreign clients to interface with the FDA and to attend FDA meetings with our clients, including pre-IND end of phase 2 and pre-NDA conferences.