Supply Shortage Management Plan 4 June 2020 Case studies A French pharmaceutical firm (generic products) was directed by the French Health Authorities to prepare a Supply Shortage Management Plan (SSMP) for one of its medicinal products used in the context of a temporary recommendation for use*. This was a…
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…
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.
