Virtual Clinical Supplies Department
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.
Our service portfolio is thus not restricted to consulting only but also comprises functions like coordination between clinical development as "customer" and clinical supplies department als "order fulfilment" function up to taking over the complete function of a virtual clinical supplies department.
We take care for planning and realisation of requirements as given by study protocols, the respective communication with clinical, with CROs and all other involved parties (e.g. Pharmacovigilance, Quality Management, Regulatory Affairs, GMP etc.) and manage all the plannings up to a committed written supplies request (as laid down in EU GMP Annex 13).
Once this is available we design the packaging concept (based on the box-in-the-box-in-the-box principle; see figures) as with a Matrjoschka puppet and take care for the labelling texts and sufficient stability / shelf-life.
We make sure that all requirements (as e.g. given in a SLA Service Level Agreement) are complied with following target costing and project management principles.