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Nitto Denko Avecia Inc

10 Vanderbilt

Irvine, CA 92620 US


Founded in 1988 as Irvine Analytical Laboratories, Irvine quickly evolved into a respected testing facility providing analytical-through-formulation support for many of the nation's leading pharmaceutical, biotechnology, and medical device companies. In response to the growing needs of our customers, we've recently expanded our depth and breadth of services and expertise in pharmaceutical development to ensure support through preclinical, clinical, registration, and commercialization.

Our fully-compliant cGMP services include method development and validation, analytical chemistry, stability storage and testing, comprehensive microbiological support, preformulation and formulation, drug delivery testing, inhalation and nasal testing, biopharmaceutical support, and much more.

Technical Information:


Analytical Development

Method Development and Validation
Process Validation Support
Cleaning Validation and Verification
Comparator Studies and Reference
Standard Qualification
Microbiological Testing

Quality Control Testing
Research and Development Testing

Aseptic Fill-and-Finish

Process Validation
Lyophilization
Scale-up Studies
Packaging and Labeling
Stability Storage

Standard and Custom Storage Conditions
in Accordance with ICH Guidelines

Biopharmaceuticals

Method Development and Validation
Product Characterization and Quality
Control Testing
Structural Chemistry

Extractable/Leachable Studies
Reference Standard Characterization
Structural Elucidation of Unknowns
Investigational Studies

Drug Delivery Device Technologies

Inhalation/Nasal Product Testing
Transdermal Product Testing
Device Evaluation

DISCLAIMER: This Laboratory Profile was provided by the company above.