Health Sciences

  1. NovaTox offers a range of services supporting the pharmaceutical industry. NovaTox Senior staff work equally successfully with virtual and near-virtual firms, with mid-size firms that may have their own toxicologists, and with Fortune 500 pharmaceutical companies.

Computational Predictive Toxicology

  1. NovaTox is pleased to announce the availability of comprehensive computational predictive toxicology services to assist the pharmaceutical and chemical industry. We have been requested over the last three years to provide on-going assessments related to potential chemical impurities or degradation products in drugs, foods, cosmetics and consumer products. The computational tools now at our disposal have become an integral part of safety assessments allowing us to assist clients in completing safety assessments and risk-prioritization strategies. NovaTox Inc. is now a user of DEREK Nexus developed by Lhasa Ltd., of Leeds, UK, a knowledge-based expert system for the prediction of toxicological hazard. DEREK Nexus is a knowledge-based predictive modeling system used to predict the toxicological hazard of chemical entities based on structural similarities to known toxicants. NovaTox works closely with pharmaceutical firms and chemical companies needing to meet the ICH M7 guidance for impurities “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk,” in addition to other regulatory requirements. We are able to use the models to assist clients that require comprehensive safety assessments related to extractable and leachable chemicals in drug products, impurities in drug product formulations, and assessing the potential safety of impurities and other chemical entities found in various consumer products (supplements, vitamins, cosmetics, natural health products). 

  2. NovaTox specializes in providing scientific and regulatory support and advice in drug product development to manufacturers of pharmaceutical and biopharmaceutical products, in addition to consumer healthcare, and consumer product clients. We provide expertise on non-clinical aspects of drug development by designing practical strategies to support conventional development programs or to address unique safety issues that may impede regulatory approval.

Drug Toxicology and Pharmaceutical Support

  1. As a core element of our health sciences and pharmaceutical support business, NovaTox designs, conducts, monitors and reports on both GLP and non-GLP safety pharmacology, toxicology, and pharmacokinetics and drug metabolism studies according to FDA and ICH regulatory guidance documents. We have significant expertise in toxicological problem solving. Our senior staff and associates have managed more than 50 non-clinical development programs, from initial CRO selection, protocol design, monitoring study conduct, data analysis to comprehensive reporting. We are also available to assist clients for meetings with regulatory authorities (Health Canada, FDA), including provision of comprehensive support and face-to-face meetings with regulatory authorities. 

Pharmaceutical Environmental Assessments for FDA Filings

  1. As part of the New Drug Application (NDA) filing process with the U.S. FDA, NovaTox can perform environmental risk assessments for new pharmaceutical ingredients. Following review of all pre-clinical data, we assist clients by selecting, overseeing, and interpreting all required testing that is used in the environmental assessment (EA) expert report. 

  2. Our environmental exposure and ecological risk assessments allow for an optimally targeted testing program designed to demonstrate that additional testing for environmental depletion of the APIs are not required. This strategic approach will result in a shorter environmental testing phase and an earlier submission of the NDA to the FDA.

Legal & Business Development Support

  1. We have expertise in providing comprehensive Gap Analysis and due-diligence services related to candidate drug selection, due-diligence on pharmaceutical firms, and CROs.  NovaTox can assist clients in the process of acquiring potential IP and other related acquisitions. 

  2. Other services that we offer include the provision of guidance on the regulatory consequences of specific toxicology findings. As highly trained toxicologists, we are skilled at noting deficiencies and inconsistencies in study reports, so that problematic findings or interpretations can be addressed before the regulatory submission is finalized. We are also skilled advisors on implications of regulatory agency requests regarding preclinical issues. Recently, we have been asked to advise on current industry trends in toxicology and non-clinical CROs.