Offers/Services

• Advice on and development of registration strategies.
• Preparation and checking of the form and content of registration dossiers for Switzerland.
• Drawing-up of expert appraisals and reports.
• Complete regulatory care of products.
• Drawing-up and submission of applications for acceptance of drugs by the health insurances, price increases, acceptance of new package sizes or dosage forms by the Federal Office of Health, incl. advice on pricing, negotiations with the Federal Office of Health etc.
• Checking and drawing-up of standard operating procedures (SOPs) in the field of quality management/responsible person/GDP.
• Support of pharmacovigilance
• Interim management, e.g.:
  - Taking-over of all work in the field of regulatory affairs during holidays
  - Catching-up with pending matters
  - Taking-over of individual projects (variations, health-insurance plans etc.)
  - Familiarization and/or coaching of personnel (e.g. as Assistant and/or Manager of Regulatory Affairs)
  - Responsible person
  - Preparation, accompaniment and follow-up of inspections
  - Advice on the drawing-up of standard operating procedures (SOPs); drawing-up of SOPs
  - Answering of enquiries (medical-scientific, pharmaceutical)
• Quality management:
  - Taking-over of the functions of the responsible person, incl. batch release
  - Training in regard to GDP/GSP. Consultancy in regulatory matters
  - Checking of advertising material (Kodex, Law on Drugs)
  - Standard operating procedures (SOPs)
  
  

If you wish, I would be pleased to carry out my work on your premises (in the Zurich, Aargau, Basel , Berne and Central Switzerland regions).

Testimonials and references: on request.