Pre-Formulation & Formulation Development

Clients come to us with a wide range of molecule including small molecules, oligonucleotides, vaccines, peptides, biosimilars, mAbs, and large protiens. 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. Our goal for formulation development is to obtain a safe, effective product that is stable for years after manufacturing.

CheckMarkSolubility, pH, Forced Degradation with Heat, pH Adjustments, Peroxide, and Light

     Excipient Studies, Co-Solvent Investigations, Short Term Stability

CheckMarkDose and Route of Administration Analysis, Bulk Preparation, pKa and pI Studies

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.

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CheckMarkLyophilizer – LyoStar II Freeze-Dryer

CheckMarkDevelopment/Optimization of Lyophilization Cycle


Crystalline/Amorphous Characterization, Thermal Stability 


Differential Scanning Calorimetry (DSC), Dielectric Analysis (DEA)

CheckMark Differential Thermal Analysis (DTA), Thermoelectric Analysis (TEA)

CheckMark Freeze-Dry Microscopy, Technology Transfer for Manufacturing

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. We specialize in executing phase appropriate method validations which will support that method during each step in the drug approval process.

CheckMarkMethod Transfer: Verification, Qualification, Validation

CheckMarkMethod Development/Optimization

CheckMarkLiquid Chromatography, Gas Chromatography

CheckMarkIon Chromatography, Capillary Electrophoresis

CheckMarkBioAssays, UV-Vis, Particle Analysis

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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 –

Learn More About Our Development & Testing Services