Tag / regulatory affairs
News • Jan 13, 2017 09:53 CET
NNIT is ready to help Life Science companies in the United States overcome the challenges they are facing.
Press releases • Oct 25, 2016 09:37 CEST
International partnership delivers solutions and services to support identification of medicinal products.
Press releases • Jun 29, 2016 10:00 CEST
NNIT, a leading provider of IT services and consultancy, announces that it has signed a five-year agreement with Ambu on outsourcing the company’s IT infrastructure to NNIT. Ambu, a leading manufacturer of diagnostic and life-supporting devices for hospitals employs NNIT to host the company’s IT infrastructure.
Press releases • Jan 28, 2015 12:53 CET
Right now, Danish and European pharmaceutical companies are gearing up to comply with the ISO standards – designated IDMP – that come into force in the EU on 1 July 2016. The ISO IDMP standards require information from many areas of the pharmaceutical business, including regulatory affairs, research and development, manufacturing and distribution.
News • Jan 09, 2015 14:56 CET
To prevent counterfeit, regulation requiring serialization is enforced. But even serial numbers can be counterfeited, especially if batches have sequential codes. Enter the need to generate unique bar codes and serial numbers that are not computed algorithmically. Such capability also needs to operate globally to ensure compliance around the world. NNIT's SafeCoder does exactly this.
News • Jul 01, 2013 10:00 CEST
Drug makers are facing an ever-increasing challenge as more countries implement serialization and tracking regulations and set compliance deadlines in an effort to ensure the safety and quality of prescription drugs being sold within their borders. Complying with regulations coming into effect will be a demanding task due to a lack of global harmonization.
News • Apr 12, 2013 09:00 CEST
Regulatory approval for pharmaceutical products can be difficult to obtain, not least because the submission process is often slow and prone to errors. Thomas Svendsen and Peter Noes of NNIT tell World Pharmaceutical Frontiers how regulatory teams can use a business intelligence tool to monitor submission status and hasten time to market.