Toxicological Risk Assessment (TRA) is an assessment report to a product or ingredient in a product, which is defined as a comprehensive safety evaluation report for a specific ingredient or contaminant in the product. Technically TRA is given by the toxicologist after reviewing the scientific knowledge of all the information of the product or the data of specific ingredient within the content of nature of the product, dosage and concentration of the product and the exposure scenario.
The main objective of the toxicological risk assessment is to evaluate the potential health risks associated with exposure to leachable impurities, contaminants, or other residues in a medical device or drug product. The hazard risk assessments are majorly based on the chemical characterization of a test article, information that is published from the toxicological literature, and tolerable exposure limits, which may be adopted from the regulatory guidelines or based on available toxicology data derived.
TRA report mainly evaluated by the following activities:
Hazard identification and data evaluation.
Exposure assessment.
Dose-response analysis.
Risk characterization.
Maven team have the acknowledged toxicologists whose have an immersive experience in toxicological risk assessment in pharmaceuticals, food, medical devices, cosmetics and general chemicals.
Maven Expertise in Regulatory Toxicology:
Pharmaceuticals
Cosmetics
Food
Medical Devices
Consumer Products
General Chemicals
Benefits from Maven:
Cost-effective
End-to-end Regulatory consultation
Qualified team of experts with hands-on experience across all categories of personal care, house hold and Personal Hygiene products like detergents, surface cleansers, toiletries, insect repellent products.
Expert support for region-specific Regulatory complexities
Interactions with Health Authorities (HAs)
Structured approach to ensure quick product launch or market access.
Welcome to Maven, one of the best Regulatory Consultants that is setup by real life working professionals with very rich experience. We at Maven understand the customers pulse and reach their expectations. We are unique and focus on quality is our prime goal. Maven works with any range of company that is looking for quality and in time delivery of services.
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