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BlueReg Group   White papers

White papers

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22 October 2020

Medicinal products & medicinal substances incorporated in medical devices

The implementation of the European Medical Device Regulation, Regulation (EU) 2017/745 (MDR) and the publication of numerous guidelines could increase the already existing confusion about the association of medicinal product or medicinal substance with medical device. The objective of this…

White papers

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6 May 2020

Evaluation of the risk of nitrosamine impurities

"During the summer 2018, authorities become aware of the presence of some nitrosamines in API – (Valsartan – presence of N- nitrosodimethylamine (NDMA) - other sartans – presence of N-nitrosodiethylamine NDEA).   These nitrosamines were already known as probable carcinogenic compounds…

White papers

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1 March 2018

Development of Advanced Therapy Medicinal Products in Europe

  Advanced Therapy Medicinal Products are innovative and complex medicinal products for which successful development requires a good understanding of the applicable regulatory requirements.   This WhitePaper on Advanced Therapy Medicinal Products (ATMP) in Europe, adapted from the article published…

White papers

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27 February 2018

New European Regulation on Clinical Trials, rules and implementation, where are we?

  Clinical Trials (CT) are currently regulated under the Directive 2001/20/EC. The Directive had a positive impact on the safety, ethic and reliability of data from CT. However, limitations were soon evidenced such as a decreased number of CT in…

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Welcome to BlueReg, an international consulting company for the pharmaceutical industry, specializing in development, regulatory affairs, economic affairs, quality and pharmacovigilance. We have built long-term partnerships with many clients by offering them “tailor-made” services guaranteeing expert advice and efficient solutions, thus supporting their projects towards success.

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