in
N/A
Certifications
- ISO
- EMA (EU GMP)
- World Health Organization (GMP / HACCP)
- TGA (Australia GMP)
Activity
- manufacturing
Features
- Uses:
- Toxicity (OEB classification):
- DEA: N/A
- BSL:
- Therapeutic areas: N/A
- Markets: COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), EMA (EU), CDSCO (India), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), SFDA (Saudi Arabia), Turkish Health Authorities
Batch Size / Reactor
Services
- Regulatory services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Tech transfer, Scale-up, Primary packaging, Secondary packaging, Labeling, Serialization, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission
