Regulatory Affairs
Bridging product development to market authorisation
Regulatory Affairs (RA) drives global regulatory strategies for Novo Nordisk’s products from preclinical development through post-approval surveillance and marketing – whether they are biological, medical devices or combinations. We are well versed in orphan drug and fast track submission and negotiation.
Novo Nordisk markets its products in 179 countries. RA obtains and maintains the market authorisations for all products and is responsible for all product labelling.
Our track-record with agency inspections of global manufacturing sites is solid. As a pharmaceutical manufacturer Novo Nordisk works together with the authorities to bring the best possible therapies to the patients as fast as possible. Therfore, we always give high priority to the stringent safety and efficacy testing procedures as well as to documentation of the quality of the products.
Along with a comprehensive regulatory strategy, our experienced staff helps achieve successful product development with timely availability of high quality regulatory documentation and effective communication skills. We provide both the strategic and tactical input to the rest of the R&D organisation.
Our expertise
We are skilled and knowledgeable within topics such as regulatory intelligence, regulatory risk assessment, regulatory due diligence and interacting and negotiating with global regulatory authorities.
Once a treatment is on the market, we take it into the lifecycle management phase, where we monitor continuing clinical trials and keep in contact with authorities.
RA maintains and updates existing authorisations, and handles variations that often require regulatory approval before implementation, such as changes in production methods.
See our other units in R&D
Diabetes Research Unit
Biopharmaceutical Research Unit
Global Development
CMC Supply
