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European Medicines Agency (EMEA) invites software company NAGARRO to Amsterdam convention of TOPRA


The European Medicines Agency (EMEA) has invited NAGARRO to introduce its regulatory software SureDoc(TM) at the Amsterdam convention of The Organisation for Professionals in Regulatory Affairs (TOPRA). The invitation is the result of a stringent multi-level evaluation of solution concepts by the Agency. Joydeep Dash, NAGARRO Europe’s coordinator for the pharmaceutical sector, is very pleased: “The fact that we were chosen to take part in the TOPRA convention is a validation of our expertise in the sector in general and in the regulatory domain in particular. In the past, NAGARRO has also worked on regulatory applications involving the FDA (Food and Drugs Administration) and the FAA (Federal Aviation Administration) in the US.”

The EMEA coordinates the evaluation and monitoring of pharmaceuticals in the entire European Union. The Agency brings together the scientific resources of the 25 EU Member States in a network of 42 national competent authorities. It cooperates closely with international partners, reinforcing the EU contribution to global harmonization. As development partner, high demands are being set on NAGARRO with respect to process definition and quality of application development. In addition to these technical qualifications, deep experience in the area of health care and pharmaceuticals is expected. “We have proven in the last 8 years that we are a competent, experienced and efficient partner for major and medium-sized enterprises in the health care sector”, says Vikas Sehgal, head of the international pharmaceutical division. “Regulatory pharma is a mission-critical and demanding environment and only the best software companies can venture into it.” Vikas will also be attending the presentation in Amsterdam.

Founded in 1996, NAGARRO serves customers in the USA, Europe and Asia through a global delivery model, emphasizing local services combined with offshore development. In addition to offering custom and customized software for process control to portal implementation, the company has been offering the leading product management system “Projistics” since 2002.

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