Our analytical development group has experience supporting a range of generic and branded pharmaceutical dosage forms—from injectables, solid dosage forms, semi solids and transdermal products. They have an in-depth understanding of all facets of the drug development process, including gap analysis and remedial validation of methodologies to comply with US FDA and globally recognized ICH guidelines.
Nitto Avecia Pharma Services is experienced in designing detailed protocols for method development, validation, and technology transfer to ensure the success of the drug development phase. Throughout the process, we serve as a responsive partner, providing analytical solutions that address your drug development priorities, timelines, and budget.
We provide a complete solution for analytical development and validation, streamlining and simplifying your drug development workflow. From phase-appropriate validation and commercial support to gap analysis and remedial solutions to meet CMC regulatory requirements, support for comparative studies, and counterfeit product evaluation, we can provide the reliable results you need to achieve your goals.
We complement the expertise of our team with state-of-the-art instrumentation. To deliver accurate, repeatable results we use a range of technologies and techniques, including fast resolution/high resolution chromatography, HPLC/UPLC, GC/MS, LC/MS/MS, LC-Q-TOF, IC, DSC and TGA, ICP-MS/ICP-OES, and others. We continually invest in new technologies to give our customers an edge.
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
