MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients
CATÉGORIE / PRODUIT: FDF / PRODUITS PHARMACEUTIQUES, OLIGONUCLÉOTIDES, INGÉNIERIE DES PARTICULES, CHIMIQUE-SYNTHÉTIQUE
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), Service public français (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (BPF de Chine), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Conseil de recherche sur le halal, INVIMA, Santé Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (République de Corée GMP), COFEPRIS
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
BSL (niveau de sécurité biologique): 3, 4, 1, 2
USAGE: Humain
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
RÉGION: APAC
OEB (bandes d´exposition professionnelle): 2 (PDE = 1 000 - 5 000 µg/jour), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)