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Thousands of datasets | CMC strategy | NDA and BLA | process development evidence | eliminate experimental rework | fast creation of regulatory control documents
During process development, you will collect thousands of datasets, across many unit operations, which must be collated into a cohesive development report that will serve your CMC strategy and ultimate NDA or BLA filing.
Working externally across a process development and manufacturing network of partners often feels like you are losing control of these critical datasets, not having them at your fingerprints when you need them. We believe this slows you down so we built a first-in-class digital data management platform, called iACHIEVE™, which our technical and project management teams use every day, to capture and share every datapoint directly with as it is collected.
This digital-first approach to process development makes tech transfer easier. By having development reports and raw data to hand as we collaborate on the tech transfer strategy for your asset, we can base scale-up decisions, equipment selection and batch record creation on sound process development evidence. This approach eliminates experimental rework late in development and enables faster creation of regulatory control documents.