Pharmaceutical Toxicology

Our toxicology and risk assessment services leverage both literature and In Silico approaches to ensure the safety and compliance of various pharmaceutical API’s and excipients.

 

With the growing demand for integrated safety and compliance solutions, our toxicological interpretation alongside our testing and investigation services delivers a holistic approach to pharmaceutical product safety and regulatory compliance.

 

From assessing new active pharmaceutical ingredients (APIs) and excipients, impurities and residual solvents to evaluating contaminants through extractables and leachables (E&L) hazard screening and full assessments. We support clients with toxicology data strategies and dossier preparation, ensuring robust and reliable risk assessments.

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+44 (0)118 918 4000
lifesciencesales@rssl.com
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Toxicology Services

 

We provide expert evaluations of health risks associated with various substances, contaminants, and materials, bespoke to your product using desk-based (encompassing literature, threshold techniques (TTC), read across amongst other techniques) , tailored risk assessments.

 

Delivered by our expert team using established models and published, peer reviewed literature, we will support you with an array of services including the following:

 

 

  • Predicting toxicological effects: Leveraging expertise within In Silico modelling and read-across techniques to predict toxicological effects and fill data gaps when direct data is lacking.

 

  • Submission support: Dossier and submission support to aid clients in adhering to regulatory standards, including those within the EP and USP. 

 

  • Facilitating acute testing: Hazard evaluation assessments, supported by literature reviews and In Silico models, using frameworks to facilitate acute development and sensory testing.

 

  • Quantitative Risk Assessment: QRA analyses to determine safe exposure levels, including DNELs, through comprehensive literature reviews and data gap analyses.

 

 

  • Specific suitability evaluations: Evaluations of material suitability for specific materials within a specified application, including packaging, medical device and 3D printing, with thorough literature reviews and gap analyses

 

 

Our services are crucial at various stages of pharmaceutical product development ensuring regulatory compliance and safety. During product development, we perform risk assessments on new APIs, excipients, and novel technologies which provide key information, equipping clients to make decisions which aid safety throughout the product lifecycle.

 

Additionally, our expertise in investigations and R&D allows us to react promptly to product defects, contaminations, and potential recalls. 

 

The toxicological methods adopted by RSSL offer several benefits including tailored project and risk assessments aligned with the clients required legislative framework, along with rapid desk-based screening of large libraries of compounds due to our high-throughput capabilities.

 

In Silico toxicology modelling approaches such as QSAR, are also increasingly recognised as a valuable compliment to traditional testing methods, our experts identify the right modelling tool for assessments, reducing the need for extensive investigations and thus cost and time.

 

With current regulatory and public demand for humane alternatives to animal testing, In Silico methods consider ethical factors by reducing this requirement.

 

With a deep understanding of the pharmaceutical pipeline, a proven track record for supporting clients through not only routine product development but also contamination and product safety issues, you can be assured you have chosen the right toxicology partner.

 

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