Experience
We have provided our Services since 1999 to many clients in all phases of Drug Discovery and Development, and in all sorts of indications. Only a part of that work has been published, which gives an impression of the area's that we are working in (see Science). Our work has been used for internal decision making and in regulatory submissions. We work for small companies, such as startup's, but also for the largest pharmaceutical companies.
We perform our Services according to a modern Quality Management System, with state-of-the-art modelling tools.
Quality
We provide and maintain a high standard of our services by working with a modern Quality Management System, based on ISO9001 concepts. Data-management, model-based analyses and simulations, reporting and communication are performed according to Standard Operating Procedures, thus ensuring integrity, traceability and reproducibility (FDA 21 CRF part 11) of the analyses. We perform our services following all relevant guidelines from regulatory agencies (FDA, EMA and PMDA).
Furthermore, LAP&P's Quality Management System ensures that all information obtained from the sponsor and all generated results will remain strictly confidential.
Tools
Most of our work is performed using a PSN-based in-house developed NONMEM interface, integrated in R. This allows us to keep track of an effective model development process and generate graphics and reports in an automated way. When necessary, we can rely on other tools, such as Matlab, Maple, Julia, and Berkeley-Madonna.