We are a dynamic team of experts passionate about pharmaceutical development and commercialization and its complex regulatory universe. Our objective is to make this regulatory universe more navigable for our clients, minimizing their product’s time-to-market while assuring the highest quality and compliance with current regulatory expectations.
We are a dynamic team of experts passionate about pharmaceutical development and commercialization and its complex regulatory universe. Our objective is to make this regulatory universe more navigable for our clients, minimizing their product’s time-to-market while assuring the highest quality and compliance with current regulatory expectations.
María José López Barragán, PhD
Partner
Pepa is a former US FDA regulator with 15 years of combined experience in facility compliance, drug regulatory affairs (CMC) and multiple aspects of research and development at government and industry. As an FDA regulator, Pepa led pre-license and for-cause regulatory inspections of biopharmaceutical manufacturers in eight countries and contributed to the approval of 15 biotechnology drug products for US commerce. Pepa was responsible for the product safety assessment of investigational new drug (IND) applications, assessed over 200 post-approval regulatory submissions, and participated in a number of formal FDA meetings. Pepa received two FDA Special Recognition awards for her facility inspections and BLA assessment contributions to the Center of Drug Evaluation and Research, Office of Pharmaceutical Quality (CDER/OPQ).
Prior to serving at the FDA, Pepa was principal scientist at a global pharmaceutical company where she participated in the discovery and development of new antimalarial drugs. She held other senior scientist position focused on the molecular diagnostics of rare genetic disorders, and later became a principal consultant at a global CRO firm prior to founding Barragan BioConsulting. In her first year as a consultant, Pepa has served clients in three continents providing them with regulatory support in submission preparation (CMC sections), advice on regulatory strategy, and facility compliance matters.
Pepa holds a PhD in Biochemistry and Molecular Biology by Complutense University (Spain) and was a visiting research fellow at Harvard (US) and Freiburg (Germany) Universities. She completed a five-year postdoctoral fellowship at the US National Institute of Allergy and Infectious Diseases, has co-authored 20 peer-reviewed scientific publications and one biotechnology patent, and has been invited speaker at several scientific and regulatory conferences.
Antonina Nikolova, PhD
Partner
Antonina (Toni) is a former US FDA regulator with 20 years of combined experience in drug regulatory affairs (CMC) and multiple aspects of research and development in government and industry.
As an FDA regulator at CDER/OPQ/OBP, Toni was responsible for the CMC assessment of over 50 investigational new drug (IND) and BLA applications, over 100 post-approval regulatory submissions, and participated in a number of formal FDA meetings. She is now recognized as an expert in Biosimilars, having held positions in industry including Regulatory CMC Advisor and Vice President-CMC.
Prior to serving at the US FDA, Toni was a scientist at the Johns Hopkins University, Center of Pulmonary and Critical Care Medicine, where she conducted research focused on the regulation of pulmonary endothelial cell barrier function. Upon leaving the US FDA, Toni held several consulting positions, serving clients in USA, Canada, Europe, and Asia, providing regulatory support in CMC submission preparation and regulatory strategy.
Toni holds a PhD in Human Genetics from the University of Maryland at Baltimore (UMAB), School of Medicine. She completed her postdoctoral fellowship in the Laboratory of Molecular and Developmental Immunology at the US FDA and has co-authored 10 peer-reviewed scientific publications. Toni has been invited speaker at several scientific and regulatory conferences, most recently at the World Vaccine Congress, Washington D.C. and RAPS, Montreal, Canada. Toni speaks Bulgarian, English, Russian, and German with native proficiency.
Marine Joly-Battaglini, PharmD
Partner
Marine is a pharmacist by training with over 10 years of experience in the pharmaceutical industry, holding different positions in CMC development and commercialization of new drugs. Her experience includes projects spanning from chemically synthesized products with oral and topical routes of administration (liquid and semisolid dosage forms) and parenteral products, including monoclonal antibodies.
Marine has been responsible for regulatory submissions to the US FDA, EMA and Health Canada, as well as other regulatory agencies in Asia, Middle East, and the LATAM region. Marine has also developed expertise in the creation and revision of monographs for the European and United States Pharmacopeias.
Marine holds a Master of Science in Pharmacy by the University of Geneva, Switzerland, and a Master’s degree in Regulatory Affairs by Université Paris Cité, Paris, France. Marine speaks French, English and Spanish with native proficiency.
Yuexia Li, PhD
Partner
Dr. Yuexia Li brings extraordinary experience in Regulatory Affairs, Facility Compliance, and Quality Assurance, acquired at the US FDA and industry sector (including pharma, biotech, in vitro diagnostics, and gene therapy) for over 20 years combined.
While at the FDA, Yuexia held a Deputy Office Director position at CDER/OC/OPRO (Office of Program and Regulatory Operations), and Associate Director for Regulatory Affairs at CDER/OPQ (Office of Lifecycle Drug Products), among other positions.
As a consultant, Yuexia has held positions such as VP, Technical at PAREXEL International and WE Conduit Consulting LLC, where she provides a full range of technical and business consulting services across multiple disciplines of services including representing clients to Regulatory Agencies.
Yuexia holds a PhD degree in Molecular Biology and Virology from the University of Alabama at Birmingham and completed a postdoctoral training at the US National Institute of Allergy and Infectious Diseases (NIH/NIAID), Bethesda, MD. Yuexia speaks Chinese and English with native proficiency.
Katerina Deverell, Chem. Eng.
Partner
Katerina is a Global Regulatory Affairs and Pharmaceutical industry expert with 10 years of experience holding different positions. Katerina initiated her regulatory career being responsible for eCTD publishing and various aspects of regulatory submissions for lifecycle management and new marketing authorisation applications through to managing large projects such as DCP and CP procedures, working with regulatory consultancies and big pharma on generic (both OTC and Rx), biosimilar and innovative products covering a wide range of therapeutic areas; infectious diseases, immunology, cardiovascular, CNS, respiratory, women’s health, pain management, vaccines.
Currently, Katerina is managing various projects in Regulatory affairs: Project management for divestitures, EU procedures, Regulatory strategy, CMC projects, and Clinical trial applications.
Katerina speaks Czech, Russian and English with native proficiency.
Katerina holds a degree in Chemical Engineering by the University of Chemistry and Technology in Prague, Czech Republic, and is currently getting her Master’s degree in Regulatory Affairs by the University for Continuing Education in Krems, Austria.