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About MAI
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CATEGORY / PRODUCT
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BATCH SIZE
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STAGE
Investigational
Commercial (Phase IV)
USE
Human
Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC)
(A) Digestive tract and metabolism
(B) Blood and blood forming organs
(C) Cardiovascular system
(D) Dermatologicals
(G) Genito urinary system and sex hormones
(H) Systemic hormonal preparations excl. sex hormones and insulins
(J) Antiinfectives for systemic use
(L) Antineoplastic and immunomodulating agents
(M) Musculoskeletal system
(N) Nervous system
(P) Antiparasitic products, insecticides and repellents
(R) Respiratory system
(S) Sensory organs
(V01) Allergens
(V04) Diagnostic agents
(V06) Nutrients
(V09-10) Radiopharmaceuticals
OEB (Occupational Exposure Banding)
1 / low-hazard (PDE > 10,000 µg/day)
2 (PDE = 1,000 - 10,000 µg/day)
3 (PDE = 100 - 1,000 µg/day)
4 / HPAPI (PDE = 10 - 100 µg/day)
5 / HPAPI (PDE < 10 µg/day)
BSL (Biological Safety Level)
1
2
3
4
CONTROLLED SUBSTANCES
Lowest potential for abuse
Low potential for abuse
Lower potential for abuse
High potential for abuse & medical use
High potential for abuse & no medical use
COMPLIANCE
PMDA (Japan)
TGA (Australia)
MHRA (UK)
Health Canada
NMPA (China GMP)
ANVISA (Brazil)
ISO
World Health Organization (GMP / HACCP)
ICH
FDA (cGMP)
NSF
EMA (EU GMP)
PMDA/MHLW (Japan GMP)
NMPA (China GMP)
Health Canada (Canada GMP)
MHRA (UK GMP)
TGA (Australia GMP)
MFDS/KFDA (Republic of Korea GMP)
TITCK (Turkish Health Authorities)
UAE Ministry of Health & Prevention
SFDA (Saudi Food & Drug Authority)
ANMAT (Argentina nueva GMP)
ANVISA (Brazil B-GMP)
ISP (Chile BPM)
INVIMA
MSPAS
COFEPRIS
DIGEMID
Roszdravnadzor (Russia GMP)
IFS
SQF (Safe Quality Food)
BRCGS
Halal Research Council
ECOVADIS
French Service-Public (CIR)
MARKETS
Rest of World
FDA (USA)
EMA (EU)
PMDA (Japan)
NMPA (China)
MHRA (UK)
Health Canada (Canada)
TGA (Australia)
CDSCO (India)
MFDS (South Korea)
Turkish Health Authorities
EDE (UAE)
SFDA (Saudi Arabia)
ANMAT (Argentina)
ANVISA (Brazil)
ISP (Chile)
INVIMA (Colombia)
MSPAS (Guatemala)
COFEPRIS (Mexico)
DIGEMID (Peru)
Russian Health Authorities
SERVICES
Development services
Manufacturing services
Analytical / QC services
Quality Assurance services
Regulatory services
Packaging
Logistics