Pacific Link Consulting has decades of experience with pre-clinical development and studies. We have guided companies with new compounds through the initial pre-clinical trial process including pharmacodynamics testing, metabolism and pharmacokinetics testing and toxicology testing with the goal of finding a safe dosage of the compound to begin clinical trials in humans.
PLC can work with in-house staff or manage hired vendors for your pre-clinical project. We have partnerships with several experienced consultants in different regulatory environments, including Japan, that can guide and help with the goal to bring your compound to IND filing.
PLC can assist with:
- In Vitro research
- In Vivo research
- Initial dose range-finding including single and multiple-dose administration protocols
- Active Pharmaceutical Ingredient (API) preparation
- Formulation Studies
- Safety Studies
- Absorption, Distribution, Metabolism and Excretion (ADME) Studies
- Follow Good Laboratory Practices (GLP)
- Complete program of pre-clinical toxicology services
- Validating efficacy of compound
- Ascertaining best mode of application of compound
- Drug Formulation
- Study design
- Data interpretation
- Quality Assurance
- Other activities and regulatory assistance that support IND application
The services listed above are not comprehensive. If you would like to learn more about how we can help your pre-clinical trial needs or have any questions, please don’t hesitate to contact us.