Industry: Medical Device/Combination Products
Client: Medical Device Manufacturer
Issue: Evaluation and compilation of nonclinical data for an Investigational Device Exemption (IDE).
How We Helped: Scientists at ToxServices compiled nonclinical data for incorporation into an IDE and responded to Agency comments on same. This included quality assurance review of the study design and conduct to ensure results were compliant.
Industry: Consumer Products
Client: Toy Manufacturer
Issue: A manufacturer of a squeezable, fluid-filled toy received numerous complaints from parents reporting that children ingested the fluid-filling of the toy. Testing commissioned by the manufacturer identified numerous aliphatic and aromatic hydrocarbons in the fluid.
How We Helped: Scientists at ToxServices searched and evaluated the published literature to identify critical health effects data for each hydrocarbon extracting from the fluid. Based on this analysis, scientists at ToxServices were able to reassure the client that the fluid in the toy did not pose a significant risk of adverse health effects.
Industry: Pharmaceutical
Client: Pharmaceutical Manufacturer
Issue: Pharmaceutical manufacturer required auditing of testing facilities.
How We Helped: Scientists at ToxServices conducted pre-study audits of toxicology and bioanalytical testing facilities to ensure compliance for Sponsor studies. We identified substantive compliance issues at the intended bioanalytical facility and, working with the Sponsor, quickly identified an alternate bioanalytical facility to ensure Sponsor studies would be fully compliant.
Industry: Pharmaceutical
Client: Pharmaceutical Manufacturer
Issue: The Client was concerned that workers were being exposed to unsafe levels of pharmaceutical agents released into the air during the manufacturing process.
How We Helped: Scientists at ToxServices performed a comprehensive literature review and analysis of toxicology and pharmacokinetic studies in order to identify critical health effects associated with inhalation of specific pharmaceuticals. This analysis was then used to develop 8-hour occupational exposure limits (OEL) for the client's use. Based on the OELs provided, the client was able to employ rational, cost-effective safety measures to protect its workers.
Industry: Dietary Supplement
Client: Dietary Supplement Manufacturer
Issue: Scientists at ToxServices evaluated the safety of a dietary supplement that contained numerous ingredients for which there were no established FDA Reference Daily Intakes (RDI) or Institute of Medicine Dietary Reference Intakes (DRI).
How We Helped: Scientists at ToxServices reviewed each ingredient of the dietary supplement, evaluated the safety of each ingredient, and recommended the elimination of two potentially toxic herbs and a reduction of the level of a specific trace element in order to make the product safer. By implementing these changes, the client was able to bring its product to market in a safe and cost-effective manner.
Industry: Contract Research
Client: Contract Research Organization
Issue: CRO needed extra staff to handle an unexpected increase in workload.
How We Helped: Scientists at ToxServices provided quality assurance and study directing services to a client whose workload temporarily exceeded internal resources. We were able to quickly master client SOPs to ensure QA activities and study direction were fully compliant with GLP and internal practices. In this capacity, our scientists have provided report writing services to ensure the client was able to meet contractual obligations of report delivery timelines. Our extensive experience in non-clinical research and mastery of GLP regulations ensured the CRO was able to deliver a quality, compliant product to their client in a timely fashion.
Industry: Potable Water
Client: Certification Organization
Issue: Private companies that test thousands of products for compliance with ANSI-accredited standards lack the toxicological expertise to evaluate their test results.
How We Helped: ToxServices has on-going contracts with several certification organizations and testing laboratories to provide cost-effective toxicology support services. With more than a decade of experience evaluating products against NSF standards, ToxServices reviews many of the new drinking water system components, drinking water treatment units, and direct drinking water additives that are brought to market.
Industry: Legal
Client: Litigation Counsel
Issue: Attorneys wanted to evaluate the potential merit of mass claims against an American company for adverse health effects allegedly arising out of gold mining activities in South America.
How We Helped: ToxServices worked with the legal team to develop an appropriate sampling protocol for use by a public health nurse dispatched to the area to investigate. By working with ToxServices before conducting the investigation, counsel was able to ensure that data and samples gathered would accurately reflect the reality of the claims, reducing the costs of having to do further investigations.
