Global Regulatory Affairs (GRA) Outsourcing Platform 18 February 2020 Case studies A global biopharmaceutical company entrusted to BlueReg the management of daily regulatory activities for a large portfolio of medicinal products in various therapeutic areas, the objective being to focus their internal resources on strategic projects. The outsourced activities encompassed development…
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…
