Our experienced team of regulatory affairs consultants has knowledge and expertise that span all types of products such as traditional pharmaceuticals, generics, cosmetics, vaccines, biologics and biosimilars, and other advanced therapies. They have held key positions in the pharmaceutical industry as well as within the national authority and can support all your strategic and operational projects through highly valuable business and regulatory expertise.
Our Leading Healthcare Professionals
Meet the key experts of our team:
Dr. Nicolae Fotin is a visionary leader who has been a driving force behind many positive changes in the field of medicines’ regulatory affairs. With over 20 years of experience as a physician and almost 15 years of experience in the regulatory field, both at the level of the competent authority, National Agency for Medicines and Medical Devices, and in the private sector, he has a deep understanding of the industry. Dr. Fotin has held several leadership positions within the National Agency for Medicines and Medical Devices (the Romanian regulatory body), including serving as the President of the agency for several years.
Gabriela Ruja is a pharmacist and former GMP and GDP inspector with more than 15 years’ experience working within the Romanian National Agency for Medicines and Medical Devices. She was the Agency’s representative in the Inspectors Working Group at the European Medicines Agency, took part in international inspection teams with fellow EU inspectors, performing GMP inspections at both manufacturers of finished products and active pharmaceutical ingredients. As an auditor of the pharmaceutical quality system, she was actively involved in the assessment audits of other EU medicines agencies (within BEMA and JAP programs of the Heads of Medicines Agencies). She joined Media Kompass in February 2019, as consultant in the field of GMP and GDP compliance.
Daniela Nicolescu is a primary pharmacist and principal scientific researcher, with long-running experience in medicines quality control and scientific documentation development and evaluation regarding “Module 3 – Quality” in application dossiers for marketing authorisation of medicines, as well as coordinating these activities as Quality Department Head within the national competent authority – National Agency for Medicines and Medical Devices of Romania. She has developed new generics medicines and also new analytical methods for products that have been authorized in EU countries, Asia and USA. She represented NAMMD in the Quality Working Party (QWP), within the European Medicines Agency. She is currently a senior consultant on pharmaceutical documentation.
Marina Popescu has long-standing experience in the field of drug authorization and constructively complements Media Kompass’s spectrum of specialties as a chemical engineer. She trained in the field of pharmaceutics while at the NAMMD and over the years has evolved from chemical analyst to quality assessor for generic medicinal products obtained through chemical synthesis, authorised under MRP/DCP or centralised procedures. Moreover, she represented NAMMDR in the Quality Working Party (QWP) and Name Review Group (NRG) within the European Medicines Agency (EMA). She developed significant expertise in pharmaceutical regulations as a member of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). Based on her extensive background in the field of authorisation of medicinal products for human use, Marina Popescu is currently a senior regulatory consultant within Media Kompas.
Dr. Andreea Elena Nițu joined Media Kompass in 2020, actively participating in pharmacovigilance activities within local medical literature screening and engaging in Health Technology Assessment activities related to medical devices.
Dr. Nițu holds a medical degree from „Carol Davila” University of Medicine and Pharmacy, as well as bachelor’s and master’s degrees in Economics from the Academy of Economic Studies.
Irina Crețu graduated from the National University of Political Studies and Public Administration, Department of International Relations and European Integration. Irina joined Media Kompass at the beginning of 2020 as translation coordinator, with over 10 years of experience in medical translations. Now, she works as a Certified Quality Management System Specialist, as part of the Regulatory Affairs team.
Mădălina Duță is a graduate of the University of Bucharest with a degree in sociology. She joined Media Kompass in 2010 and worked for several years in the media monitoring department, gaining knowledge in the field of pharmaceutical legislation. Later on, she started working in the Consultancy and Services department of Media Kompass and since 2020 participated in development of the training courses for medical devices.
Currently, she is mainly in charge with the activities related to regulations in the field of medical devices as well as medicinal product advertising.
Violeta Melicescu is an economist, specialized in European Union Affairs and certified English translator with over 13 years of experience in medical translations. Violeta is PECB certified data protection officer for Media Kompass since 2018. She is currently coordinating the PIL readability team, having 10 years of experience in this field.
Eliza Miclea joined Media Kompass in 2011 and holds a bachelor’s degree in Social and Administrative Studies, specializing in International Relations and European Studies. In the early years, Eliza worked in the media monitoring department and specialized in monitoring public tenders. In early 2020, she joined Media Kompass PIL’s readability testing team, having over 10 years of experience in this field.
