We provide global and robust expert toxicology consulting services to pharmaceutical, biotechnology and medical device companies and their products.
Toxicological Risk Assessments (TRA)
The relationship between a hazard and potential for exposure defines risk. Toxicological risk assessments determine whether or not a product poses a potential risk for the toxicological endpoints measured and, if desired, can be amended to also include suggested labelling phrases, warnings and warning symbols that may be necessary on the package of the product.
► Each ingredient is assessed for its hazard or "inherent" toxicity such as acute toxicity, skin/eye irritancy, potential for skin sensitization, reproductive, genotoxic, or carcinogenic activity, in relation to the potential for consumer exposure to the chemical
►characteristics of the product such as physical form and size/volume
► accessibility (e.g. liquid components)
► intended use
Scientific and medical writing services
Our medical and pharmaceutical experts have diverse scientific knowledge and extensive experience of pharmaceutical development to produce clear and concisely worded documents for medical and pharmaceutical companies worldwide. Based on our industry experience and regulatory interactions, we are able to prepare a diverse range of medical and pharmaceutical documentation to address the needs of various stakeholders, medical monitors, study coordinators and regulatory reviewers.
● Product Monographs, Package Inserts, etc.
Establishing Health-Based Exposure Limits
● Perform assessments and prepare reports that are compliant with the EMA guideline
● Work with clients to prepare tailored assessment reports for proprietary and generic drug substances/products that address
the requirements of the EMA guideline.
Extractables and Leachables Studies
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