
Patheon by Thermo Fisher Scientific
https://patheon.com
Linz
Linz
Austria
Linz
Austria
Categories
About Patheon by Thermo Fisher Scientific:
Thermo Fisher Scientific provides pharma services solutions for drug development, clinical trial logistics, and commercial manufacturing to customers through its Patheon brand. With more than 65 locations around the world, they provide integrated, end-to-end capabilities across all phases of development, including API, biologics, viral vectors, cGMP plasmids, formulation, clinical trials solutions, logistics services, and commercial manufacturing and packaging.
Service Offerings:
- Small molecule and polymer API production for clinical and commercial materials (cGMP. Halal. Kosher)
- Production scales ranging from 100 kg to hundreds of metric tons
- Optimization and upscaling of chemical processes
- QbD approach (Quality by Design)
- Process development from the early clinical phase up to commercial production
- Analytical method development and phase-appropriate method validations
- Proven Acceptable Range (PAR)
- Process safety studies
- Stability studies
- Solid-state investigations
- Micro reactors/flow chemistry for developmental quantities and commercial productions
- Process transfers
- Raw material sourcing and outsourcing
- External manufacturing
- Registration
- Validation
- Product launch
- Support customer’s filing activities (CMC. DMF
- Regulatory support (audits of any regulatory authorities. registration/validation. ICH stability studies. support and consultancy in filing strategy. filing of regulatory documents for submission [NDA/CMC. DMF])
Reviews:
No Reviews