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
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Technology transfer
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Scale-up/Validation
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Expert regulatory filing strategies for the Americas, Europe, Asia Pacific and ROW
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Fill/Finish
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Custom kits and packaging
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Full product release (including QP) and stability testing
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Supply and cold-chain management
One 2 One offers a full range of product development services. Guidance is provided throughout the latter stages of the development process as well as on drug delivery systems designed to enhance existing product offerings. Innovation and drive fuel the R&D team and provide the foundations of our analytical and development services, tailored to match your unique needs.
As the need for biologics and complex molecules continues to grow, One 2 One specialized services plays an expanding role in the development process. Our focus is on two specific areas:
- protEcol™ Services - the manufacture of active biologic ingredients as well as production of recombinant peptides and proteins in E. coli
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ImpurID™ Services - Identifying, qualifying, and quantifying unknown impurities in your product
The One 2 One Global Regulatory Affairs team is focused on the regulatory success of your product. The team provides comprehensive support for each parenteral product throughout the global registration processes. Included is expertise in:
- Common Technical Document format (CTD)
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e-submissions
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global filings, strategies for the Americas, Europe, Asia Pacific and ROW
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review, approval, and post-approval phases, including annual reports
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handling inquires from the FDA, EMEA, MHRA, Health Canada and other regulatory agencies
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supported more than 250 regulatory submissions and more than 25 DMFs over the last five years for One 2 One customers