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