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Gens & Associates ranks NNIT as a global leader in Regulatory Information Management system implementations
NNIT has evolved quite dramatically over the years, from a small independent IT consultancy born out of Novo Nordisk to a publicly listed company and now an international group of companies in its own right. This article is the second in a series looking at the individual NNIT Group Companies.
Brooke Casselberry recognized as one of industry’s most inspiring
We asked Jesper Borgstrøm, Advanced Advisory Consultant, NNIT Life Sciences – Regulatory Affairs, to take us through the safety aspects of one of the world’s most regulated product development and manufacturing processes.
Together, Kinapse and NNIT will deliver world class regulatory, pharmacovigilance and clinical business process outsourcing services.
ISO IDMP is the next wave in the pharmacovigilance legislation after xEVMPD. But with a global scope and requiring data integration from the entire company it is a much bigger wave. ISO IDMP will transform your regulatory IT strategy.
Since the implementation of Directive 2010/84 and Regulation 1235/2010, marketing authorisation holders (MAHs) with products on the European market are obliged to maintain, and make available upon request, a Pharmacovigilance System Master File (PSMF).
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