FormaliS uses its experience to find answers to your Quality Management questions.

Activity:

  • Support, Consulting and Assistance in the GLP and GCLP area
  • Analysis and/or improvement of existing Quality Management Systems
  • Design of new/alternative Quality Management System
  • Review of study documents, such as guidelines and contracts
  • Design of new/alternative Trial Master File systems

Scope:

  • Pre-Clinical studies
  • Animal studies
  • Analytical laboratories

Standards:

  • OECD GLP
  • WHO GCLP
  • Local Regulations
  • Animal Welfare Practice (AWP)