Services

Nonclinical Development

Whether developing a first-in-human drug candidate or a new indication for an existing compound, a key requirement is the development of a compelling nonclinical safety package and rationale for the use of the product. Alava’s consultants are experienced in all aspects of nonclinical development including GLP-compliant toxicology studies to enable clinical assessment and eventual commercialization. Our lead consultant has been responsible for nonclinical development of over 80 first-in-human projects including more than 40 biologicals, as well as numerous products in late stage development. Supported activities include:

  • demonstrating mechanism of action
  • pharmacodymanics and pharmacokineticsspecial safety studies (cardiotoxicity, reproductive toxicology, genotoxicity)
  • selection and development of test species
  • selection and management of global CRO’s, including study conduct, compliance and study reports
  • interpretation of results and building the framework for for clinical development
  • advice on EU and international development
  • biologicals, advanced therapy medicinal products (ATMP), small molecules and devices