Method Development and Validation
Your laboratory partner in developing, transferring, or validating methods must have significant experience with relevant analytical technologies, as well as a thorough understanding of the regulatory environment. Microbac has that expertise.
Microbac can assist your company, whether your needs include start-from-scratch method development, improvement of a problematic method, or validation of a tried-and-true method.
Microbac can provide support through the technical and regulatory issues associated with the development, optimization, or validation of analytical methods, including methods that are part of an NDA or ANDA submission, or are to be used for a ready-to-sell product.
Method Development
Microbac’s scientists have developed and validated multiple chromatographic and spectroscopic assays and dissolution methods for clients. These include methods for API and finished products.
Method Transfer
Microbac provides on-site assistance in transferring our methods to clients, and have demonstrated proficiency in transferring methods from our clients. We assist with typical and novel drug delivery systems, including immediate and extended-release formulations.
Method Validation
Microbac will assist with or execute Validation Protocol per USP, FDA, and ICH Guidelines. We can verify the stability-indicating nature of methods through forced degradation and confirmation or identification of degradation products. For chromatographic methods, our stability-indicating detection capabilities include diode array and mass spectrometry.