We offer
Qualified person (QP)
Book now your Qualified Person (QP) for Switzerland and be assured that an expert takes care of your products and reporting.
Book now your Qualified Person (QP) for Switzerland and be assured that an expert takes care of your products and reporting.
on-demand - dedicated expert
- Client owns budget
- Invoiced monthly at a fixed rate
- Working against task order
- On-site availability of expert
- Mid-term assignment
As a service, Avanti Europe will provide a dedicated expert in the role as your QP or Responsible Person (RP). The QP can be booked as part-time resource in full compliance with Annex 16 of EU GMP.
Our experts in the role of your QP comply with the qualification demands from the Medicinal Product Directive (MPD) 2001/83/EC Article 49. The role of the QP will cover the aspects of:
tuning to your demand
- Client defines processes
- Client defines products
- Client defines time frame and frequency of reporting
- Digital data exchange
- Back-traceable reporting
Our experts acting as QP under your pharmaceutical quality system (PQS) require access to documents and information in order to fulfill their tasks best. Digital access is here the best choice but thanks to our versatile approach, paper documents can be used as well.
An Avanti Europe expert acting as the QP needs access to at least the following documents:
optimized cost structure
- Depending on process landscape
- Depending on number of products
- Depending on number of outsourced manufacturing steps
- Depending on work-load
- Invoiced as a monthly fixed rate
Costs are transparently fixed at the beginning of a term. A term can be individually set or prolonged with a minimum of 6 months in order to benefit from the tool set of a QP and its expertise.
Depending on the volume of documents and number of products, the QP can be booked starting at a very low work load percentage. Depending on demand, further development, expansion of the market or alike, the QP resource can be easily scaled to the demand.
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