Nonclinical Toxicology Support

knoell USA provides nonclinical toxicology support for all phases of drug development from early discovery through NDA. Our experts have many years of relevant industry experience in toxicology and safety pharmacology.

Nonclinical Toxicology Support: General Specialties

  • Toxicology program design
  • Toxicology study outsourcing
  • Design, management and interpretation of toxicology and safety pharmacology studies
  • Regulatory document preparation and representation
  • In licensing/due diligence support

Specific Capabilities and Deliverables

  • Toxicology protocol development
  • CRO selection and qualification, competitive bidding, favorable cost and timeline negotiations.
  • Study monitoring
  • Critical review of draft toxicology reports
  • Authoring of nonclinical sections of Investigator Brochures, INDs, NDAs and similar regulatory documents
Mike Derelanko, PhD, DABT, FATS Technical Lead Toxicology
+1 610 558 3001 Ext. 123 send mail

The knoell network: worldwide experts

We offer a comprehensive, modular service portfolio based on the unique "Glocal Concept": worldwide industry sector know-how with experience in the key global markets – and local presence at your company. Discover the knoell network: