Clinical QMS Support

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

Activity:

  • Support, Consultancy and Assistance in GCP-related matters.
  • Analysis and/or improvement of existing Quality Management systems
  • Design of new/alternative Quality Management systems
  • Review of study documents, such as guidelines and contracts
  • Design of new/alternative Trial Master File systems

Scope:

  • Clinical Studies from Phase I to IV
  • All Therapeutic Areas
  • Medical Devices
  • Biotech Products
  • Development of SOPs

Standards:

  • ICH GCP
  • FDA Requirements
  • EU Directives and Guidelines
  • Local Clinical Trial Regulations