Novo Nordisk spinout, SAP team up to offer regulatory compliance services

EMA

The IT services offshoot of Novo Nordisk ($NVO) has teamed up with SAP to help companies comply with upcoming regulatory changes. NNIT, the Novo spinout, has created the service in response to changes to the format and terminologies drug developers must use when sending data to the European Medicines Agency (EMA).

EMA is currently in the middle of implementing the changes. Specifically, the regulator is adopting specifications the International Organization for Standardization (ISO) has set for the identification of medicinal products (IDMP). EMA sees the phased introduction of the ISO standard making it easier to exchange information, notably by supporting interoperability within Europe and beyond. But, as with any change, the new approach could create some near-term headaches for companies.

Recognizing this, NNIT has hooked up with SAP to design a service intended to ease the transition for its clients. The partnership, which builds on a relationship that goes back more than a decade, is seen by SAP as a meeting of complementary technologies.

“By collaborating on IDMP, we combine the powerful capabilities of the SAP HANA platform together with NNIT's regulatory expertise and profound legacy within IT services outsourcing for the life sciences industry,” Joe Miles, global vice president for life sciences at SAP, said in a statement.

HANA is a computing platform designed to manage and crunch data, either as an on-premise or cloud-based system. The platform has made some inroads into life sciences, signing up organizations including Stanford School of Medicine as customers. And SAP has used HANA as the basis for its life science-focused offerings, such as its pitches for the precision medicine market SAP Foundation for Health and SAP Medical Research Insights.

For NNIT, HANA is a platform on which to build its attempt to turn the introduction of IDMP into an opportunity to grow its customer base. After years of speculation and preparation, plus a false start, NNIT struck out on its own earlier last year, in part to help it hoover up more business from clients other than Novo.

Sales to life science companies other than Novo increased 16.5% last year, although its former parent company still accounts for the majority of NNIT’s sales to the industry. Services that address IDMP, serialization and other regulatory shifts are one part of NNIT’s growth strategy.

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