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Pre Clinical Toxicology

Toxicological risk assessments form an integral part of a drug's developmental life cycle. Along with cosmetic and other healthcare consumer products, we provide a full suite of custom non-clinical safety and toxicology evaluation services for both large and small molecule products. Optimizing nonclinical plans using our integrated approach means we can help our clients identify the most promising compounds in their libraries.
 
For many smaller biotech or pharmaceutical companies, limited resources means focusing internal efforts on the chemistry/manufacturing and proof-of-concept pharmacology studies. In such cases, clients often have limited guidance or experience with IND-enabling nonclinical studies.

We aim to help our customers “trim” time of your early development studies by streamlining study designs and generating “value added” data that best position drug candidates for First-In Human (FIH) trials. The efficiency gained during this critical early-period for “non-revenue” generating assets reduces investment costs, increases shareholder value, and meet the “3R” principles of animal welfare

Aligning your non-clinical data to support your clinical plan is key in preventing scrutiny from regulators closer to MAA/BLA/NDA approval and we take pride in the substantial number of studies we have contributed to.

Non-clinical Regulatory Support

  • Designing and monitoring of non-clinical studies including ADME and PK/TK

  • Responding GNA/RFI

  • Agency interactions for IND enabling battery and support during SA procedures

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Non-clinical Writing Services

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Bespoke Toxicology Services

  • Environment risk assessment

  • Biocompatibility plans, reports and assessments

  • Impurity qualification and risk assessment

  • DART studies, Genetox and Safety pharmacology study designs

  • Due diligence of early-stage assets for investors (VC/PE/Healthcare Funds) to assess investment risk

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