pharmacology

Toxicology plays a crucial role in the pharmaceutical industry by ensuring the safety and efficacy of drugs throughout their lifecycle. Intertox supports clients in identifying, assessing, and documenting the potential toxicological hazards of drug product impurities and other components to meet the rigorous standards of regulatory bodies around the world. We work with clients to meet the requirements of regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for establishing drug product safety prior to achieving product approval. We have over 35 years of experience conducting toxicological assessments to support the pharmaceutical, medical device, and other industries, and are deeply familiar with regulatory processes and how to help our clients meet challenges on the path to successfully developing new medical products and bringing them to market. 

Intertox assists clients with regulatory issues throughout all stages of development and introduction into the market. Our comprehensive services encompass strategy, planning, and oversight to ensure compliance with FDA requirements. We also offer marketing, authorization, and product life cycle management programs.

• Pharmaceutical manufacturers face many challenges regarding safety of their ingredients and products. During the manufacture, transfer, packing, distribution, and administration of drug products, chemicals can leach into the product from external sources, including manufacturing components, drug delivery devices, and final container closures. Chemicals can also be introduced from other sources, creating a potential hazard to patients. Manufacturers are also challenged with establishing the safety of other non-active ingredients, including excipients and other impurities, as well as residual processing components at applied doses.

• Extractables and leachables (E&L) testing of pharmaceutical products is critical to characterize the potential hazards of leachable impurities and establishing patient safety. Intertox helps clients understand, describe, and document the potential toxicological hazards of drug product impurities and other components to meet the requirements of regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for establishing drug product safety prior to achieving product approval. We have one of the largest databases of active ingredients to assess potential hazards. With over 30 years of experience conducting toxicological assessments, we are deeply familiar with regulatory processes and how to help our clients meet challenges on the path to successfully developing new medical products and bringing them to market. 

• Designed an in silico model for a global insurance company to predict nano-risk during product appraisals for insurance applications.
• Evaluated workers’ risk of exposure to airborne nanoparticles while sanding and grinding composite materials containing carbon nanotubules.