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