Engineering - implementation - supervision

Practical experience

We offer elaboration or assistance in processing of the documentation which is an integral part of a successful project from the initial idea to the first manufactured tablet:

  • assignment (a basic document for processing a project)
  • URS (User Requirement Specification)
  • RA (Risk Analysis)
  • VMP (Validation Master Plan)
  • all stages of project documentation (see DESIGN)
  • specification of equipment, space, system of production and distribution of pure media
  • DQ (Design Qualification)
  • Quality Plan

We will help you to consult the project with the state regulatory authority (SÚKL).

We provide:

  • communicating of customer's requirements to suppliers
  • project management (HIP)
  • technical support in the selection of supplies
  • author and technical supervision
  • commissioning of all equipment and systems

company motto

REGULATIONS MUST NOT BLOCK COMMON SENSE!!!

Pharm Partners
references

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PHARMA SYNTEZ
PRO.MED.CS
Institute for Nuclear Research
FAVEA spol. s.r.o.