Successful commercialization starts 2-4 years prior to launch, right after proof-of-concept, as you move through Phase II trials. We continually partner with you, guiding your product from site selection and technology transfer to cold-chain management and distribution:
- Global method and process development
- Technology transfer
- Scale-up/Validation
- Expert regulatory filing strategies for the Americas, Europe, Asia Pacific and ROW
- Fill/Finish
- Custom kits and packaging
- Full product release (including QP) and stability testing
- Supply and cold-chain management
Learn more about One 2 One product development competencies