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ToxaChemica has extensive experience in study protocol development and placement of non-clinical toxicology testing for clients. Drs. Farber and Page have over thirty years of experience in the development of toxicology testing protocols and have played major roles in the development of FDA, EPA and OECD and GLP guidelines during their extensive government service. ToxaChemica has relationships with several laboratories that have outstanding reputations for providing excellent service and superior value whose reports enjoy distinguished acceptance with regulatory agencies, facilitating product registration and acceptance. These laboratories are AAALAC accredited, GLP compliant and USDA registered and have outstanding records in regards to FDA and EPA facility and data audits. Our staff will assist the client by developing a toxicity testing strategy for a new product that complies with Federal, state and local, or international regulatory requirements. ToxaChemica will manage your product safety program, ranging from single studies to complete nonclinical programs. We will prepare protocols and will work with these testing laboratories to get the necessary work performed for the best possible price. We will monitor animal safety studies in progress to insure that they are properly conducted under GLP requirements and can provide on-site presence at key milestones in a study. Our staff will conduct third-party QA inspections for GLP studies when required. We will critically review draft study reports prior to finalization and if our clients so desire, ToxaChemica will assist the client in the publication of the findings of these studies in the open scientific literature. ToxaChemica can integrate these study data with other existing data into integrated summary documents. On completion of the studies we will present, in facilitating meetings, the study findings to regulatory authorities. ToxaChemica will prepare or preview submissions, from pre-meeting packages to complete dossiers for new active substances, for regulatory agencies world-wide.
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