Drug Development

ToxHub toxicologists, with their substantial experience in the pharmaceutical industry, will assist your researchers in the non-clinical development of your pharmaceutical products; offering different cost-effective business solutions, all tailored to suit your needs and resources and to speed up the time to the marketing of your products.

ToxHub consulting scientists provide a comprehensive range of services in non-clinical toxicology to support the first-in-man of drug candidates. Thanks to our extensive experience in non-clinical development we can support the safety of your product during the research, development and industrialization phases. In addition, our toxicologists will assist you in the maintenance of your already marketed products to be compliant with the upcoming local or international regulations within a Life Cycle Management process.

  • De-risking of drug candidates in early discovery phases by custom-made tox-strategies including: design, timeline and results evaluation of in silico (QSAR), in vitro and in vivo investigational non-GLP studies.
  • Toxicity and Safety Pharmacology study identification and protocol design; laboratory proposal management and assistance with laboratory selection including site visits; on-site study monitoring; study data interpretation and study report review (GLP and non-GLP).
  • Investigation of Mode of Action and relevance for humans concerning toxicological effects.
  • Non-clinical services related to a Paediatric Investigation Plan (PIP) according to the European Regulation (EC) No 1901/2006 and amendment: juvenile study protocols designed on your product; excipients analysis for the development of specific paediatric formulations.
  • Non-clinical local tolerance evaluation to support human exposure to a drug product (both active substance and excipients) at contact sites of the body following clinical use according to the EMA Guideline on non-clinical local tolerance testing of medicinal products EMA/CHMP/SWP/2145/2000 Rev. 1.
    • Excipient safety assessment including exposure scenario, Margin of Safety calculation, site of contact reaction assessment.
    • In vitro testing for sensitization, dermal, ocular and mucosal irritation, performed using reconstructed tissues, in GLP and according to validated models (services provided by partners).
  • Risk assessment and strategies for qualification of process impurities and other contaminants:
  • Derivation of permissible daily exposure (PDE) levels through cross-contamination in shared facilities.
  • Risk assessment for Extractables & Leachables (E&L)
  • Environmental Risk Assessment (ERA) of pharmaceuticals,
  • Derivation of occupational exposure limits (OEL/OEB) for active pharmaceutical ingredients (API) and for isolated pharmaceutical ingredients (IPI) in the work environment.
  • Non-clinical sections of INDs/NDAs in legacy and eCTD format (using client’s eCTD templates); Investigator’s Brochure.
  • Due Diligence and Data Gap Analysis.