Dominique Monferrer

Company: Asphalion S.L.

Dr. Dominique Monferrer holds a degree in Human Biology and a PhD in X-ray Macromolecular Crystallography. She worked for several years as a researcher at molecular laboratory institutions and synchrotrons in Spain and Germany before joining Asphalion as regulatory affairs consultant.

As regulatory affairs manager, her main areas of expertise include providing scientific assessment in development of chemical drugs and biologics (including biosimilars and cell-therapy medicinal products), carrying out and overseeing CMC and medical writing of regulatory documentation (e.g. IMPDs, scientific advice briefing packages, registration dossiers, etc.), as well as conducting viability analyses and designing tailored roadpmaps for innovative medical devices and in-vitro diagnostics.