toxicology, GLP  and product safety consulting and training
Product Safety Assessment & Toxicology Reviews
We provide clients with toxicology and product safety assessment guidance through preclinical and clinical testing. Our clients are also interested in acquiring preclinical safety and toxicology information. This information potentially leads to product commercialization or acquisition.
We work with clients in the evaluation and interpretation of the safety of:
  • Existing and potential products
  • Metabolites
  • Degradants
  • Impurities
  • Intermediates
  • Product acquisitions
  • Larger molecules that have been made nano-sized
We have considerable experience with the safety assessment of small and large molecules, nanoparticles and nanomaterials, as well as botanicals.
Additional services that we provide include:
  • Toxicology summaries may be prepared for potential products. These summaries can be used as part of a clinical protocol submitted to an Institutional Review Board (IRB), for inclusion in Investigator's Brochures (IB) and for regulatory submissions, in addition to management and investor presentations.
  • Scientific literature searches, review toxicology literature, publications (public and internal documentation) and toxicology study data
  • Generation of position or white papers, study reports, and manuscripts or abstracts for internal purposes, publications and for litigation support.
  • Peer review of study reports, toxicology or related papers, manuscripts, submissions, etc.
  • Document review and Quality Assurance reviews
  • Evaluation of the safety of products obtained through manufacturing process changes
  • Review license candidates and perform due diligence audits
 
   
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