Testing

GMP Testing Services In the complex drug development pipeline, there are several key areas where a need for product or materials testing becomes necessary. Singota has a unique niche for delivering these capabilities to those in need, with a specialty in parenteral product testing.

Singota Solutions provides extensive CDMO analytical development and testing services tailored to meet the evolving needs of the pharmaceutical industry. Leveraging our expertise in small batch aseptic filler technology, aseptic manufacturing, and injectable formulation development, we deliver high-quality solutions customized to our clients’ specific requirements. Our cGMP services cover a broad spectrum of critical test areas, including GMP, material identity verification, in-process, product release, and product-specific assays. We specialize in the following test services, including compendial, microbial (including endotoxin, bioburden, and sterility), CoA generation, ICH stability under all ICH conditions, retention sample management, inspection, in-use infusion studies, container closure integrity, forced degradation, transportation, as well as method validation, qualification, development, and transfer services. With our unwavering commitment to excellence and strict adherence to regulatory standards, Singota Solutions is your trusted partner for reliable and efficient test services throughout the drug development process.

At Singota, we utilize an Electronic Laboratory Notebook (ELN) to provide our clients with a 21 CFR Part 11 compliant data system for all of their analytical test results. Data from method development, QC testing, and R&D projects all is stored in our ELN system.