These concepts are rather new, and has been developed jointly between the pharmaceutical industry and health care authorities in US, Japan and Europe.

We focus on how to gain product knowledge and process understanding as part of the development process, using Quality Risk Management, Design of Experiments and Process Analytical Technology, how to submit and get regulatory approval of a medicinal product using these new approaches, and how to validate, execute, and maintain a state of control. All of which is combined with improvements of the processes at commercial scale.

Our client base includes the well-established large pharmaceutical companies, the innovators and generic pharmaceutical companies, as well as companies from the medical device industry. The client base is spread across UK, EU, US and India.

Who are we: 
Lundsberg Consulting Ltd was founded by Line Lundsberg, PhD, in the UK in 2005. She is a Danish scientist in Physics and one of the pioneers in developing and implementing these new principles for development and manufacturing in the Pharmaceutical Industry. She has previously worked for Novo Nordisk and Lundbeck before moving to the UK.  She is well recognised in the industry, a regular speaker and trainer at international meetings, collaborates with both EU (EMA) and US (FDA) regulators, author of books published by ISPE supporting practical implementation of Quality by Design.

What we hope to gain from being member of DUCC: 
The traditional pharmaceutical industry is currently changing in the UK. Many smaller research driven spin-offs and innovative organisations are being established mainly in the biopharmaceutical and device arena. We believe that a link to these organisations could be mutual beneficiary and also support UK/DK business relationships.