• Development
  • Product life-cycle management

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:

Contact us. We’re happy to help!

Hotline

Monday - Friday
08:00 - 17:00 o´clock

+49 7272 7767-0