Pharmaceutivcal development is our namegiver (PharmDev).
We are offering this activity also as "virtual pharmaceutical development department" such that your own ressources are reliefed from this burden. We are making use then of our well established provider network to set up a development team being the leader ourself.
We usually follow ICH Q8 and either develop the necessary DoEs with our own tools or using commercial software like Modde . The biggest challenge according to our experience, however, is presented at the very beginning: to draft the Quality Target Product Profile, which actually is something like a URS. Difficulty is in getting the involved parties committed to a long range target. We do know how to obtain these most important commitments for development projects. We have listened to all concerns of all involved disciplines for years and none of those concerns can really frighten us - on the contrary, we know how to get these concerns constructively included into the target setting process..
We are embedding these activities into a professional project management taking over responsibility for deadlines and ressources according to a one-stop-shop concept: our clients just have to define - together with us - the target and then expect the results. Any activities in between are professionally pursued by us. We are managing the outsourcing activities and controlling and supervising deadlines and results. In so far our clients are doing outsourcing of outsourcing - a very successful concept as the past has shown.
At least the following activities are covered:
a) Setting up pharmaceutical target profiles (Quality Target Product Profiles QTPP including Critical Quality Attributes and Critical Process Parameters according to ICH Q8) and development plans (following your or our own development handbook)
b) virtual contract development
c) "virtual" quality control of development products (see also PharmQP Contractors)
d) Development of intellectual property rights combined with strategies for positioning and realisation of these IP for pharmaceutical development related topics (pharmaceutical IP generation & strategy)
e) conducting due diligences in the area of pharmaceutical development with company assessments and inlicensing projects (contract due diligence assessments)