Regulatory Competence for Russian Federation and CIS
Dr. Edelgard Rehak
Dr. Edelgard Rehak Consulting is a European service provider for Pharmaceutical Companies with focus on business in Russian Federation and former Soviet Union (CIS) countries. Our core competences are new registrations and maintenance of registrations of medicinal products and medical devices in Russian Federation, CIS and EAEU region. We offer the services of preparation and supervision of GMP inspections by Russian and EAEU authorities, preparation and monitoring of local bioequivalence studies and due diligence of registration dossiers.
We offer more than 30 years of experiences in development and registration of medicinal products and medical devices for the international markets.
Together with our local partners in Europe and Russian Federation as well as former CIS Countries we are integrated into a strong international network of experts.
Dr. Edelgard Rehak is an invited speaker to international congresses, expert for arbitration procedures and supports national associations in Europe.
Nearly the complete business career of Edelgard Rehak was strongly connected with the business in former Soviet Union countries. From 2011 till 2015 she was working in Moscow holding the position of the Head of Regulatory of Sanofi in Russian Federation, and from 2007 till 2010 she was leading the Regulatory Department and QA of NOVARTIS in Kiev, Ukraine.
In Moscow she was also in charge of implementing a Centre of Expertise for Bioequivalence and toxicological studies for generic portfolio of Zentiva.
Dr. Edelgard Rehak Consulting offers competent services for all questions in Regulatory Affairs. A transparent, flexible, cooperative and on time cooperation with our local and international business partners is the key of our success. GxP compliance has highest priority.
Our strong local and international network will help our clients to find the best local partner for your business.
In 2017 Dr. Edelgard Rehak has become co-owner of the RM Beteiligung GmbH, a company focused on new concepts in pharmaceutical industry and other business areas.