Anistème is quality conscious and ensures that all activities comply with the regulatory requirements. We have our own Quality Assurance Unit and our team is committed to quality assurance standards that ensure reliable results and uncompromised service.
All our subcontractors are also required to work to quality assurance standards.
Pre-clinical studies are conducted in the CRO's test facilities in compliance with Good Laboratory Practice (EU Directive 2004/10) and using Standard Operating Procedures. These experimental farms are also accredited for experimentation by veterinarian services. All studies are performed in line with European legislation for animal well-being (Directive 86/609 and applicable OECD guidelines). Anistème scientific reports follow GLP requirements.
Veterinary clinical studies are conducted in compliance with Good Clinical Practice. Anistème's monitors conduct inspections of study critical phases and the veterinarian investigators have a wealth of experience in clinical studies and are committed to GCP. All our studies are performed in accordance with local regulations for veterinary clinical trials and veterinary ethics. Anistème protocols and study reports follow GCP requirements (VICH Topic GL9).
Protocols, raw data and reports are audited by our Quality Assurance Unit and quality reports are fully documented.