ATVIO's expert team can assist you in leading your assays through the state-of-the-art development process, qualification and validation of unique product assays for quality control, in-process control, release, safety and stability tests.
Analytical assays are a key element of any drug product. It allows us to characterize the product and be certain of its safety and quality. The product should be monitored throughout the manufacturing process in order to identify and understand critical parameters that can influence the quality of your product and your process.
Our team will reassure the reproducibility of your assays, help you to identify the correct potency assay for your product and provide you with a strong scientific support for generating a high-throughput, high-quality and validated assays according to the relevant regulatory authorities (i.e., FDA, EMA).
Moreover, we are able to design and generate new assays customized to your need.