Common business processes of pharmaceutical development and clinical supplies preparation require (even, or better: in particular if degree of outsourcing is increased) a very high level of qualification of involved employees. To enhance this (also non-GMP) qualification via training measures has been our business for two decades.
Furthermore we can relief your employees by taking over some or all of their activities in cases of peak uitilisation and overload.
In such cases of capacity constraints we are offering a comprehensive portfolio of supporting services e.g.
- taking over the entire supply and value chain of IMP preparation for single studies or whole projects as "virtual clinical supplies department"
- procurement of comparators ("Comparator Sourcing")
- Import of IMP and Comparators from third countries
- QP releases
- inspection readiness preparations
- document generation (e.g. SOPs or development reports)
- support with setting up URS
- take over of entire development projects with accountability for deadlines of completion