Overview – Our Services
We offer the complete range of services according to customer needs assuming Total Process Ownership on every level.
Customer Interface Levels
Flexible end-to-end service
Full service or single steps
Rottendorf Pharma expertly addresses the full spectrum of contract pharmaceutical manufacturing, packaging and formulation development for solid oral dose forms. This includes transfer services to optimize manufacturing methods as well as robust analytical services and formulation development.
It is the customer’s choice to pick the full service range or only the required single service step. Rottendorf does not manufacture its own brands, and therefore is never in competition with our clients. Rottendorf’s state-of-the-art Development Center takes customers from dosage form design and formulation optimization to upscaling and analytical methods development. The drug product moves into the transfer phase for optimization to large-scale processes and validation, including granulate and bulk manufacturing. Rottendorf can then bulk-ship or package finished drug products for commercial distribution.
- Formulation and Process Development, including optimization
- Clinical Trial Batches
- Regulatory Affairs Support
- Analytical Method Development
- Product Transfer, Validation
- Procurement of APIs, excipients, packaging materials, and more
- Bulk Manufacturing
- Quality Assurance, Quality Control
- Stability Studies