FormaliS uses its experience to find answers to your Quality Management questions.
- 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
- Clinical Studies from Phase I to IV
- All Therapeutic Areas
- Medical Devices
- Biotech Products
- Development of SOPs
- ICH GCP
- FDA Requirements
- EU Directives and Guidelines
- Local Clinical Trial Regulations