PHARMACEUTICAL
Method 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.
Whether your needs include start-from-scratch method development, improvement of a problematic method, or validation of a tried-and-true method, Microbac can help.
Whether the method is part of an NDA or ANDA submission, or is to be used for a ready-to-sell product, Microbac can support you through the technical and regulatory issues associated with the development, optimization, or validation of analytical methods.
Method Development
Our scientists have developed and validated mutliple chromatographic and spectroscopic assays and dissolution methods for our clients.
Method Transfer
We provide on-site assistance in transferring our methods to clients, and have demonstrated proficiency in transferring methods from our clients. We deal with both typical, and novel, drug delivery systems, with both immediate and extended-release formulations.
Method Validation
We 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.
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