Nitto Avecia is a contract development and manufacturing organization (CDMO) specializing in the development and production of oligonucleotide therapeutics. With over 30 years of experience, the company has manufactured more than 1,200 different oligonucleotide sequences and supports programs from preclinical through commercial supply. Nitto Avecia operates FDA-inspected, GMP-compliant facilities in Massachusetts and Ohio, and is part of the Nitto Group, sharing a vision of 'Creating Wonders.'
cGMP per USFDA 21 CFR Parts 210 and 211
Compliance program
ICH Q7 Good Manufacturing Guidance for Active Pharmaceutical Ingredients
Compliance program
EU Current Good Manufacturing Practice for Active Pharmaceutical Ingredients
Compliance program
ICH Q8 Pharmaceutical Development
Compliance program
ICH Q9 Quality Risk Management
Compliance program
ICH Q10 Pharmaceutical Quality System
Compliance program
ICH Q11 Development and Manufacture of Drug Substance
Compliance program
ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Compliance program
EUGMP
Quality certification