product life cycle management

The growing and increasingly more precisely defined regulatory requirements result in a constant pressure to adapt or optimise medicinal products that are already on the market.
Economic pressure can lead to changes in the product or process – for example, to relocations of the manufacturing business, changes in batch sizes or in the manufacturing process. The change management required for this is also subject to strict regulatory requirements.

We can offer an array of services to facilitate a successful change management process for our clients. These include the following service packages:

  • Process optimisation
  • Formula optimisation
  • Further development of processes
  • Upscaling
  • Manufacturing validation
  • GAP analysis
  • Review of regulatory compliance
  • Dossier revision and processing of variations
  • Implementation of product transfers (site transfer or technology transfer of development products)

Contact: Dr. Alexandra Keilbach-Bermann
Head of Drug Development and Production / Head of Quality
Email: a.keilbach-bermann(at)hwi-group.de
Phone: +49 7805 401-502

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