Product life-cycle management
Market changes and constantly changing regulatory requirements place manufacturers under permanent pressure to adapt or optimise medicinal products that are already being marketed.
The change management required for any changes to the product is also subject to strict regulatory requirements.
For your successful change management we offer:
- Process optimisation
- Recipe optimisation
- Upscaling
- Production validation
- GAP analysis
- Product transfer (site transfer or tech transfer)
- Method transfer
- Regulatory compliance review
- Dossier revision and variation processing
Dr. Alexandra Keilbach-Bermann
Drug Development & Production / Quality
Phone: +49 7805 401-502
Email: a.keilbach-bermann@hwi-group.de
Contact us. We’re happy to help!
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