What we do
We focus on our customer needs and support the product lifecycle covering phases starting from development, technology transfer, regulatory phase, market launch and lifecycle product upgrades.
Support with formulation development (small scale trials, test batches)
Scale-up testing (use of pilot lyo equipment assured)
All activities are fully accompanied with the relevant documentation and ensured by risk management and quality systems.
We offer a full range of ICH condition stability rooms, including photostability, where accelerated, intermediate, long-term and ongoing stability studies can be performed.
Our Quality Control team offers a range of stability studies, including:
ICH stability (25°C/60%RH, 30°C/65% RH, 40°C/75%RH)
Zone IV conditions (30°C/75%RH)
In-use stability, infusion stability
Transportation, thermal cycling stability
Analytical support activities
Quality Control adds great value to our production core-business services. Our analytical team offers:
- Development and optimization of analytical methods (HPLC, GC, AAS, etc.)
- Transfer of analytical methods
- Validation of analytical methods according to ICH guidelines
- Validation of microbial methods in combination with an external laboratory for sterility testing
- Development and validation of methods for cleaning validation
- Verification of pharmacopoeial methods
The technology transfer activities are coordinated by skilled project managers, who take care that all activities are carried out as agreed and ensure proper communication.