Our Quality unit encompasses quality assurance, regulatory support, and validation. Our FDA-registered facilities deliver products that meet 21 CFR Part 210 and 211 requirements for cGMP production. A Quality Assurance representative ensures that all applicable regulatory and quality procedures and requirements are followed throughout your project.
Nitto Avecia Pharma Services takes a proactive approach to quality and regulatory excellence. Our facilities have a successful track record of FDA and regulatory inspections. . In addition, we have been audited and client-approved by many leading pharma companies, undergoing several audits annually.
Our Quality Assurance team works with all Nitto Avecia Pharma Services departments to ensure compliance with Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR Parts 210 and 211, and other applicable U.S. FDA regulations and globally recognized ICH guidance.
We help reduce administrative burdens on customers with a range of added services, including review of chemical, manufacturing and controls (CMC) sections for client regulatory filings, as well as providing prepared templates for Quality Agreements.
10 Vanderbilt Avenue
Irvine, CA 92618
Tel: (949)-951-4425
Fax: (949) 951-4909
6 Vanderbilt Avenue
Irvine, CA 92618
4 Chrysler
Irvine, CA 92618
