For protocol-specific packaging requirements, solutions are defined on a case-by-case basis in coordination with the project manager assigned to your programme. Learn more about our packaging and labelling services at the Göttingen hub.
QP Release and Analytical Support
Clinical batch release is supported by integrated QP services and in-house analytical capabilities, covering the full scope of raw material testing through finished product release and stability.
| Service |
Scope |
| QP release |
Clinical IMP batches |
| Analytical testing |
Raw materials, intermediates and finished products |
| Method development |
Development, validation and transfer |
| Stability testing |
ICH-aligned stability programmes |
| Microbiological services |
Environmental monitoring and product testing |
All analytical activities are performed within NextPharma laboratories, supporting both clinical release and long-term product development continuity.
Comparator Sourcing and IMPD Support
Our comparator sourcing team provides comparator medication for products where market circumstances, quota regulation or restrictions from the marketing authorisation holder make sourcing difficult.
Global distribution of clinical trial material is managed from the Göttingen hub under controlled storage conditions, with dedicated customer service coordination for multi-country trial supply.
| Ambient |
Standard warehousing |
| Refrigerated |
Cold chain distribution |
| Frozen |
Down to -80°C |
| Controlled substances |
Dedicated secure storage |
Distribution covers hospitals, pharmacies and patients across study countries. Repackaging and relabelling under GMP are available within the distribution workflow.
Orphan Drug and Specialised Clinical Supply
NextPharma supports orphan drug and rare disease programmes and low-volume clinical supply requirements as part of our standard clinical trials offering.
Manufacturing and packaging processes are adapted to small patient populations, with aligned project management and documentation.
Specific capabilities include:
- Flexible minimum batch sizes
- Adapted packaging workflows for specialised dosage forms or complex handling
- Coordinated documentation and regulatory support for orphan indications
- Kanban production for complex supply chains
Read more about our orphan drug product supply and our adapted workflows for rare disease programmes.
