Dominique Monferrer holds a BSc degree in Human Biology, a PhD in Protein X-ray Crystallography, and over 6 years’ experience in academic research at the Spanish National Research Council (CSIC).
Regarding Medicinal Products, she has provided regulatory support in CMC aspects of medicinal products, including IMPDs, Briefing packages, MAA dossiers and CMC variations for chemical drugs, traditional herbal medicinal products, biologics (i.e. biosimilars) and cell-based medicinal products.
Within the area of Medical Devices, she has specialised in the scientific & regulatory assessment in development of medical devices and in vitro diagnostics, according to EU and US legal frameworks. In particular, over the years she has gained substantial experience in feasibility assessments of borderline and complex products and in the preparation of customized regulatory roadmaps for a wide-range of medical technologies. She is also very active as expert lecturer on MD regulations-related topics for a number of university programs and innovation accelerator courses for medtech entrepreneurs.
As Medical Device Director she leads a team focused on helping medtech companies and startups reach their goals in development, CE certification / FDA clearance and life-cycle maintenance of medical devices and in vitro diagnostics.
“Asphalion equals teamwork, diligence, and strong commitment, always aiming for higher standards. Its flexibility and friendly-working atmosphere are also strong marks of the firm. Along with incredibly talented and inspiring workmates and mentors it is a real privilege to be part of this organization.”
Our team possesses strong technical knowledge and long experience in the industry to help our clients in any challenge. We are very confident that with Dominique Monferrer’s leadership we will deliver great value, support and innovation to our customers. The growth of our team is intrinsically linked to that of our clients: We aim to keep growing together and envision a great future ahead.
We would like to thank Dominique for embracing this challenge.
Asphalion is an international Scientific and Regulatory Affairs consultancy company with offices in Barcelona, Madrid, Munich and London. Founded in 2000, it has consistently grown, and now employs more than 100 team members from 12 different nationalities with backgrounds in Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology and Medicine. Asphalion collaborates with Pharmaceutical, Biotechnological and Medical Technology organizations facilitating product development and regulatory affairs solutions for their projects.