Development

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, ocular, topical, and lyophilized formulations.

• Solubility, pH, Degradation, Potency, Thermal Analysis
• Vehicle delivery studies for poorly water soluble APIs (e.g.: emulsions or suspension)

Our knowledgeable and experienced group of scientists can provide 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
• Particle/droplet size reduction
• Technology Transfer

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 formulation 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.

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 pharmaceutical drug development services.