IntiQuan started its business on the 1st of December 2015. Until end of 2017 we have supported several regulatory submissions with a total of 9 regulatory PK and PKPD reports for both FDA and EMA. In addition to that we have contributed to several other projects, ranging from preclinical to Phase 2b, with valuable insights based on the available data.
References can be provided on request.
Drug Development Phases
We have experience in working across all phases of drug development. In fact, currently we have ongoing projects ranging from preclinical dose/concentration/response characterization, animal experiment optimization, human PK prediction, to population PK and concentration response (safety and efficacy) analyses for a regulatory submission. Additionally, we do have experience of support of Phase IV study designs in the context of the competitive landscape.
We have experience in the following therapeutic areas:
- Infectious Diseases (Malaria, Tuberculosis)
- Small molecules
- Monoclonal antibodies
- Therapeutic proteins
We regularly work on projects that require interactions with Health Authorities and are used to produce results and reports for such purposes. IntiQuan has a thorough Quality Management System, which is followed at all steps. Our computer system is fully validated and qualified for working in the highly regulated pharmaceutical environment.
We take our science seriously and want to contribute to a good education in the field. For this we spend some of our time developing and giving courses in Modeling&Simulation approaches (example) and contribute with workshops on conferences (example).