6 years in the Danish Medicines Agency
7 years in the pharmaceutical industry
12 years in the biotech industry

Torben Elhauge

Torben Elhauge holds a master of analytical chemistry from The Technical University of Denmark and has been employed in the pharmaceutical area since 1994. He has been employeed in Nycomed A/S, Statens Serum Institut, The Danish Medicines Agency, Life Cycle Pharma A/S, LiPlasome Pharma A/S and Egalet Denmark.

Areas of Employment

  • Development, validation, transfer and control of analytical methods
  • Systems to qualify and maintain the equipment
  • Trained internal auditor with in EN17025
  • Development and maintenance of quality systems
  • Development of monographs in expert group 10D in the European Pharmacopeia
  • Validation of methods in your own lab using relevant equipment, personnel etc.
  • Quality assessment of registration files and control of medicinal products on the market
  • Education internally and through pharmacon
  • Development and presentation of material in connection with Due Diligence
  • Development of access databases for quality systems etc

Torben have experience with performing the following registration material to both EU and FDA:

  • Analytical methods
  • Validation protocols and reports
  • Specifications
  • Stability protocols and reports
  • Comparative dissolution
  • Pharmaceutical and technical development reports
  • Have delivered registration material to the FDA leading to approval