Core Services

"Together with you, I will build your nonclinical safety program and find solutions when you meet challenges"

      Non-clinical Safety Plans:​


  • Design of non-clinical safety plans for NCEs and NBEs at all stages
  • Early toxicology exploration - derisking
  • First human dose enabling animal studies
  • Phase II and III supporting non-clinical packages
  • Pivotal studies for Marketing Applications
  • Considerations of target biology, formulation, dosing regimen in clinical trials etc.
  • Animal species qualification strategy for safety studies
  • In vitro and in vivo safety models
  • General and genetic toxicology studies
  • Safety pharmacology studies
  • Expert knowledge in reproductive, developmental and juvenile toxicology study conduct and evaluation
  • Carcinogenicity studies
  • Assessment of phototoxicity
  • Non-clinical input to Paediatric Plans (PIPs)
  • Support to due diligence


"Your benefits will be clear decision-making and confidence in the next steps of your drug development program"



Dr. Ingrid Brück Bøgh


Regulatory and scientific documents

  • Writing and review of non-clinical sections for CTD-module 2, preIND packages, INDs, IBs, DSUR/PSUR, PIPs, Marketing applications (BLA/NDA)
  • Non-clinical Risk Profiles
  • Safety evaluation prior to Clinical Trial Applications
  • Preparations and particpation in Scietnific Advice meetings
  • Scientific strategy for internal company communication
  • Writing of scientific publications for internationally peer reviewed journals

Study conduct and CRO outsourcing


  • CRO study placement, if desired quotes from several CROs can be requested

Sponsor's monitor role


  • Detailed study design
  • Protocol writing
  • Dose setting
  • In life monitoring
  • Report review and finalisatoin
  • Interpretation of results
  • Overall toxicological evaluation and risk assessment


Educational sessions


  • The role of non-clinical safety within the drug development value chain
  • Toxicology in drug development
  • Species and strain selection
  • Dose selection in tox studies
  • Dose setting for First in Human trials
  • Guideline requirements
  • Reproductive developmental assessment
  • Juvenile toxicology studies