Expert CMC advice on quality dossier preparation in support of a Compassionate Use Program in France. 28 May 2019 Case studies In the context of PRIME, a European biotechnological company entrusted BlueReg CMC team with the task of bringing the available quality data package of a synthetic peptide to global registration prerequisites for the next steps of development (the Compassionate use…
Our brand new digital brochure is now available 28 May 2019 Brochure Discover all our services and how BlueReg can provide you with strategic regulatory advice and hands-on outsourcing solutions through the entire lifecycle of your products.
New European Regulation on Clinical Trials, rules and implementation, where are we? 20 November 2018 Livres blanc 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…
Gap analysis and regulatory support in view of first in human (FIH) trial planned to be conducted in Europe 7 June 2018 Case studies A US-based customer contacted BlueReg (BR) for assistance in reviewing the CMC and non-clinical development package in view of a FIH clinical trial that will be conducted in Europe.
