Pre-Formulation & Formulation Development
Clients come to us with a wide range of molecules. We work with our clients to create a new formulation (or optimize an existing formulation) that is suitable for pre-clinical and clinical use. We deliver pre-formulation, excipient and formulation studies of parenteral, oral, and lyophilized formulations.
Solubility, pH, Degradation, Potency, Thermal Analysis
Vehicle delivery studies for poorly water soluble APIs
Process Development
Our knowledgeable and experienced group of scientists can provide drug formulation process development solutions during your product development. As your product moves through the clinical trial process into commercial manufacturing environments, manufacturing scale and processes can change. Our process development team can ensure that you are prepared for the possibilities, and able to produce a reliable product utilizing a robust manufacturing process.
Lyophilization cycle development/optimization
Technology Transfer
Analytical Development
We have extensive experience in analytical development to create a robust method for analysis of your product. Whether starting from scratch or optimizing a method provided by our clients, we offer analytical development services that are customized to your product, and can support that method during each step in the drug approval process.
Method Transfer
Optimization
Qualification
Validation
Examples include: UHPLC, HPLC, UV-Vis, CE, etc.
Additional Support
At Singota, we utilize an Electronic Laboratory Notebook to provide access for our clients to testing data, results, and reports as we complete assays and post results. This system provides communication between our clients and our team that is protected, risk-free, and simple to use. Contact us with any questions you have about our drug development services.
Contact us with any questions you have about our pharmaceutical drug development services at – solutions@singota.com