Design

According to the principles of GEP Based on good communication with the customer

Our design activities are focused on the following areas:

• pharmacy
• biotechnology
• bio/chemistry (API)
• medical devices

Our experience is valorised in designing of the manufacture of:

• liquid pharmaceutical forms
  • sterile and non-sterile
  • lyophilised products
  • high potency products (CTS, ATB, hormones)
  • vaccines
  • advanced therapy medicinal products (ATMP)
• solid pharmaceutical forms
• ointments

We submit solutions for all project stages (in full according to GEP, or according to customer's requirements):

• study, concept, feasibility study
• project documentation for building permit
• documentation for supplier selection (for tenders)
• basic design
• building documentation
• as-built documentation

We offer elaboration or assistance in processing of further documentation which is an integral part of a successful project:

• URS (User Requirement Specification)
• RA (Risk Analysis)
• VMP (Validation Master Plan)
• DQ (Design Qualification)