IRIS PHARMA AND GLP ACCREDITATION

French regulatory authority:
In 1995, Iris Pharma was granted a GLP accreditation for preclinical units by the French health products safety agency (the Agence française de sécurité sanitaire des produits de santé, AFSSAPS).

FDA:
Several agreements exist between France and the FDA. A preclinical study conducted in accordance with French standards of good laboratory practice is also acceptable in the United States of America for evaluation as part of product applications submitted for approval.

• Memorandum of understanding between FDA and french agency (1986) http://www.fda.gov/oia/Agreements/fr-phr.pdf
• Summary of the FDA-Related Elements of the " Agreement on Mutual Recognition Between the United States of America and the European Community" (1997) http://www.fda.gov/oia/mrasum.htm

IRIS PHARMA AND INSPECTIONS

Iris Pharma is regularly inspected:

• For GLP compliance for drugs and cosmetics by the French drug agency (AFSSAPS: http://afssaps.sante.fr/htm/3/indbpl.htm)
• For animal care and husbandry by the department of veterinary services
• For radiolabeled material by the nuclear security direction (DGSNR: http://www.asn.fr/sections/rubriquesprincipales/controle-nucleaire/panorama-activites/activites-industrielles in french)
• For GLP compliance for chemical products by the French association in charge of accreditation, certification and inspection of laboratories (COFRAC: http://www.industrie.gouv.fr/enjeux/gipc.htm in french)
• By our clients