Method Development, Transfer and Validation

The laboratory you use to assist you in developing, transferring, or validating methods must have significant experience with relevant analytical technologies, as well as a thorough understanding of the regulatory environment.

At Southern Testing and Research Labs, we have that expertise. For example, several of our methods have been adopted as industry-standard USP methods for vitamin assays in nutritional supplements.

In addition, our scientists have developed and validated many chromatographic and spectroscopic assays and dissolution methods for our clients. 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.

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.

Our Pharmaceutical R&D program is staffed by senior analytical and instrumentation chemists who are committed to providing quality and timely service. Our active involvement with regulatory agencies and industry associations translates to a thorough understanding of the regulatory environment, and our independent Quality Assurance Unit ensures strict adherence to cGMP guidelines at all times.

Whether your needs include start-from-scratch method development, improvement of a problematic method, or validation of tried-and-true method, Southern Testing can help. Whether the method is part of an NDA or ANDA submission, or is to be used for a ready-to-sell product, Southern Testing can support you through the technical and regulatory issues associated with the development, optimization or validation of analytical methods.

Method Development

• Expertise, Capabilities in a Broad Spectrum of Analytical Technologies

Method Transfer

• Assistance with or Execution of Transfer Protocol

Method Validation

• Assistance with or Execution of Validation Protocol per USP, FDA, ICH Guidelines