RÉGION: Europe
CATÉGORIE / PRODUIT: OLIGONUCLÉOTIDES, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, COSMETICS, SERVICES
USAGE: Humain
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ISO, EMA (BPF DE L'UE), Service public français (CIR), ECOVADIS, Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), NMPA (BPF de Chine), TGA (Australia GMP), Roszdravnadzor (Russia GMP), ANMAT (Argentine nouveau GMP), MFDS/KFDA (République de Corée GMP), ISP (Chile BPM), INVIMA, MSPAS, COFEPRIS, DIGEMID, Santé Canada (Canada GMP)
SERVICES: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging, Logistics, Quality Assurance services
TAILLE DU LOT: Petit, Grandes dimensions, Moyen
MARCHÉS: FDA (USA), EMA (EU), PMDA (Japan), ANVISA (Brazil), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), EDE (UAE)
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (D) Dermatologicals, (A) Digestive tract and metabolism, (C) Cardiovascular system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)