PreClin

aktaPD® can support your preclinical and nonclinical development processes with the effective communication and superb execution of a diverse and skilled team that includes toxicologists, basic scientists, clinical development physicians, pharmacologists, statisticians, and regulatory affairs professionals. The progressive transition of a drug candidate from early to late preclinical stages is particularly important. Our deeply experienced global experts are capable of understanding the intended clinical plan for a drug candidate and anticipating potential roadblocks so they can execute the most effective preclinical strategy. We provide a framework for defining the desired features of the new drug, known or suspected risks and liabilities, team organization, in-clinic safety monitoring programs, and metrics of success. Our goal? To help you determine your product’s ultimate safety profile.

Our preclinical / nonclinical solutions involve:

  • Target product profile
  • Pharmacology
  • Active pharmaceutical ingredient
  • Formulation
  • Analytical and bioanalytical methods
  • Pharmacokinetics, toxicokinetics, and metabolism
  • Safety and risk management
  • Pre-IND meeting
  • IND submission
  • Preclinical funding sources
  • Support / Design for clinical trial assays
  • Outsourcing

 

Need a world-class team to support you along the path of preclinical development? Contact us.