• Regulatory Affairs
  • Life-cycle management

Life-cycle management

Keep your medicinal product up to date.

The life cycle of a medicinal product never ends: new regulatory and legal requirements have to be met, technical and technological changes need to be undertaken, and documentation needs to be amended to the latest state of knowledge. You need to keep track of deadlines and communicate and implement changes with partners and the authorities.

We support you with specific aspects or we can take on the entire spectrum of necessary regulatory, analytical and technical activities. Our goal is to ensure that your products are marketed without restriction.

 

 

Our responsibilities:

 

  • Regular review and update of the marketing-authorisation dossier
  • Preparation, submission and processing of the relevant change requests for the competent authorities (e.g. variations, change notifications)
  • Planning and implementation of change-control processes
  • Evaluation and processing of deviations in, for example, procurement and manufacturing
  • Extensions/renewal applications

 

  • Monitoring and meeting deadlines
  • Pharmacovigilance tasks
  • Tasks as part of quality management
  • Monitoring regulatory compliance in the supply chain
  • Conducting audits of suppliers and service providers
  • Preparation and follow-up of inspections by the competent authorities

Dr. Andrea Klüting
Pharmacology

Phone: +49 89 2000203-60
Email:

Bettina Rankl
Quality/CMC

Phone: +49 89 2000203-51
Email:

Contact us. We’re happy to help!

Hotline

Monday - Friday
08:00 - 17:00 o´clock

+49 7272 7767-0