Integrated pre-clinical development

 

The Evotec Pre-clinical Development team can perform the full spectrum of pre-clinical studies, with the assurance of accurate and balanced assessments even when meeting the tightest deadlines. Scientists employ best-in-class technologies to find the solutions that suit client’s requirements. 

Pre-clinical team members are experts in toxicology & pathology, drug metabolism & pharmacokinetics, drug transporters and pre-clinical and clinical bioanalysis.

The Pre-clinical Department offers a full range of in vitro and in vivo GLP and non-GLP pre-clinical evaluation studies to thoroughly assess the safety profile of small and large molecules for a broad range of therapeutic areas. The team work as an extension of the client’s team helping to progress the drug development.

Efficient study designs are used in order to meet the three Rs of animal welfare aspects (replacement, reduction, refinement), while ensuring that proper scientific rigor is achieved.

Full-time veterinarians are on site and on call 24/7 to ensure the highest standards of care. They are involved in all in vivo studies and work closely with study directors, regularly monitoring and reporting on daily clinical observations and collected data.

The pre-clinical capabilities can also serve  as part of an INDiGO program,   Evotec’s solution designed to de-risk and accelerate IND-enabling programs. 

Our facility in Verona is accredited GLP by Italian Ministry of Health and AAALAC-accredited; regulatory studies are performed in accordance with OECD, EMA and FDA guidelines. 

Capabilities and services

  • ADME, PK and DDI studies
  • Bioanalysis
  • Pathology
  • Safety Assessment
  • Formulation: Collaboration with the Formulation Development team to identify and prepare the appropriate formulation for in vivo administrations
  • SEND: Collaboration with the Biometry team to generate SEND datasets for all studies conducted using internal data capture systems

Experience to support the pre-clinical development of:

  • Small molecules
  • Monoclonal antibodies
  • Peptides
  • Oligonucleotides
  • Gene therapies
  • Cell therapies

Pre-clinical activities are an important part of fully-integrated packages, including all aspects of drug development in a single site (INDiGO).

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Our INDiGO service

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