Paula Muniz is a Senior Associate with Dynakin’s Drug Modeling & Consulting (DMC) group. She is a Doctor in Pharmacy at the University of Navarra with a PhD. in cardiovascular pharmacology. She is also a MSc in Clinical Research from the University of Cardiff and an MBA from the Barcelona School of Management from Pompeu Fabra University. Paula has more than 15 years of experience within the pharmaceutical industry in an international setting where she has worked on regulatory strategy, clinical study design and result evaluation in several indications for a NCE and a fixed dose combination for EMA and FDA submissions.
Focusing on comparative bioavailability, in vivo in vitro relationships/correlations, and pragmatic application of regulatory requirements, she has participated in the development of numerous complex immediate and modified release pharmaceutical alternatives for oral, inhalation, and intramuscular routes. She has also set up and participated in scientific meetings with EMA, national authorities, and the FDA. Since her initial involvement with Dynakin she has built experience in the regulatory application of modeling & simulation and population PK/PD methods for the evaluation of interactions, pediatric product development, and bridging between populations.