Home I Contact Us I Start a ProjectStart a Project Name* First Last Company*City*State*Country*Email* Phone*What type of project are you starting?Please select...Formulation DevelopmentLyophilization Cycle DevelopmentGeneric Product DevelopmentAseptic Fill Finish & LyophilizationBulk LyophilizationComplex FormulationNon-Aseptic Fill Finish & LyophilizationAnalytical Method DevelopmentAnalytical TestingICH Stability TestingStorageLabeling and PackagingRegulatory SupportIs your product a small molecule or biologic?What it is your development challenge? (Solubility/Stability)Is your product? (Light sensitive, oxygen sensitive, prone to shear/aggregation, etc.?)Do you currently have a formulation?What is your desired drug product storage temperature?Do you need lyophilization development?What is your intended timeframe for cGMP manufacturing?What is your intended filing date?Is the formulation/process fully developed?Is your product liquid or lyophilized?Is your product a small molecule or biologic?What is your estimated batch size?What is the final use of your product?What is your intended timeframe for receiving released material?What is the scale?What kind of trays would be used?What is your intended timeframe for receiving released material?What assay do you need a method developed or optimized?Do you have a method for your bulk API or BDS release?Please share any known issues with potential assays? (No chromophore/Extremely low concentration, etc.)When is your cGMP manufacturing to be conducted?What clinical phase will the testing be supporting? Or, Commercial release?What testing do you require? IPC/Release testingDo you have a method to transfer?What is your product’s ID test?Will any testing be outsource to a 3rd party laboratory?What are your intended storage conditions?What is the length of your stability study?Is photostability required?What is the projected start date of your stability study?Do you have a stability protocol developed?What is the intended length of storage required?What is your storage temperature?Who will supply the labels and packaging materials?Please describe the secondary packaging requirements?Are the vials for clinical or commercial use?Please describe what regulatory support you are looking for?Where are your clinical trials occurring or material being distributed?What are your intended timelines for this work?Message:CAPTCHA
