Toxicology Risk Assessment (TRA)

At Plexus PreClinical Services (PPS), we provide a safety evaluation based on the composition of your product and its intended uses.

The services related to risk assessment include:

→Calculate and generate PDE/OEL/HBEL report based on a review and assessment of relevant toxicological and pharmacological data to support   the cleaning validation process

→Safety assessment of impurities & excipients 

→Toxicological Risk Assessment (TRA) for leachables & extractables (E&L) of Container Closure systems (CCS), medical devices, cosmetic products etc.

→Safety assessment and toxicological evaluation for cosmetics, fragrance & flavor products

●   Preparation and assessment of cosmetic data

●    Preparation of cosmetic product safety report (as part of PIF) as per EC 1223.2009

●    Ingredient review and label review with cosmetic regulations (EU, US, Canada, Australia, ASEAN etc)

●    Data gap analysis

●    Summarization of toxicity studies for safety assessment

→In silico - Computational toxicological analysis (QSAR) and expert review

Our toxicology risk assessment process entails:

→The toxicity of each chemical component of drug and cosmetic formulation / device is evaluated for its toxicological potential

→Evaluation of adherence to the rules for complying its compatibility with packaging.

→Assessment of adherence to the mandatory labelling requirements.