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:

Nicolae Fotin, former President of the National Agency for Medicines and Medical Devices (the Romanian regulatory body) is the visionary Leader. With an experience of 17 years as a physician, and 10 years in medicines’ regulatory field, Nicolae Fotin has been a driving force behind many positive changes in the field. As a physician he has empathy towards his patients, and as a leader he knows the “where” and the “how” of reaching those goals.

Vlad Negulescu, an excellent combination between practice – ex-Head of Health Technology Assessment Department, at the National Agency for Medicines and Medical Devices, and teaching – professor at Carol Davila Medicine and Pharmacy University in Bucharest, Romania. He joined Media Kompass in January 2019 in his new position as Senior Consultant for regulatory and HTA domains.

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 main scientific researcher, with long-running experience in medicines quality control and scientific documentation evaluation regarding “Module 3 – Quality”, from the marketing authorisation files of medicines, as well as coordinating these activities as Department Head within the national competent authority – National Agency for Medicines and Medical Devices of Romania. She has developed new medicines as well as generics while in the industry, and also new analytical methods, for products that have been authorized in EU and US countries. She represented NAMMD in the Quality Working Party (QWP), within the European Medicines Agency. She is currently a senior consultant on pharmaceutical documentation.