Product life-cycle
Market changes and new requirements constantly call for adjustments and optimisations of already market-leading medicinal products.
For your successful change management we offer:
- GAP analysis
- Process optimisation
- Recipe adaptation and optimisation
- Upscaling
- Production validation
- Adaptation of release and runtime specifications
- Establishment, development, validation of new test methods
- Product transfer (site transfer or tech transfer)
- Method transfer
- Regulatory compliance review
- Dossier revision and variation processing
Contact us. We’re happy to help!
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