Why our OSD commercial manufacturing solutions will optimize your chances of approval.
Scaling to commercial manufacturing can be arduous as you try to balance speed, regulatory, quality, and your supply chain. We understand that each small molecule and project is unique and has its own set of challenges and needs. Our range of batch, continuous, and specialized manufacturing options are created to adapt to your OSD project, while being backed by a global network and industry experts.
Short-term strategic investment for long-term cost savings
Whether it’s for scaling-up or moving to another facility, technology transfers are part of the normal course of business. In 2019, we successfully completed 119 technology transfers—44 commercial, 60 drug substance, and 15 development. Our dedicated global experts ensure:
- Process validation is in accordance with regulatory and cGMP guidelines
- Speed and agility so your project stays on track and product supply is preserved
- Seamless execution for right-the-first-time delivery
- Access to a robust system to manage the product lifecycle
- Insight to all stage gates required for each phase
- Access to stability studies, analytical data, release testing, and other regulatory documentation
Assurance and simpler logistics in your supply chains
Our breadth and depth of capabilities for commercial packaging are designed to accommodate both small and large volumes to ensure that your product can be packaged in the most cost effective way possible. Commercial packaging can help:
- Simplify your logistics
- Deliver proven technical packaging knowledge and experience
- Provide reliable service levels and focus on quality
- Enable flexibility for both small and large volume
- Streamline timelines with an end-to-end solution from development to commercial
- Allow flexibility for changes in capacity for product growth or contingency planning
Optimize your chances for approval
Thermo Fisher Scientific offers experience, reliability, and a very broad range of fill/finish commercial capabilities. We have an enviable record of oral solid dose commercialization success for our clients.
Leveraging our commercial production and clinical trials solutions will give you extensive access to global technical experts, capability, global regulatory insights, and transportation. Global network and solutions span across:
