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 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.

GMP analytical services include:

ICH Thermal Stability Test Programs

Compound

Raw material for manufacturing use

Release and CoA generation

Trials for Solubility, pH, Degradation, Potency, Purity, Reconstruction

Cytotoxic compounds

Thermal Cycling and Excursion

Materials Compatibility (e.g.: infusion sets, IV bags, stoppers, etc.)

Captisol®

Microbial (Sterility, Endotoxin & Bioburden)

Container Closure Integrity

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ICH Stability Chambers

Testing ICH Stability Chamber Testing ICH Stability Chambers Testing ICH Stability Chambers

-80°C ± 10°C; Ambient RH

-20°C ± 5°C; Ambient RH

5°C ± 3°C; Ambient RH

25°C ± 2°C; 60% ± 5% RH

40°C ± 2°C; 75% ± 5% RH

60°C ± 2°C; 75% ± 5% RH

Additional Support

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.

Contact us with any questions you have about our GMP services at: solutions@singota.com

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