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Business Areas

Clinical research

Monitoring and auditing of clinical studies in particular in Central- and Eastern Europe according to ICH-GCP, GLP and GPP.
Managing/organizing clinical studies (placement of studies, handling of the local regulatory/legislative issues, support in obtaining a marketing authorization/ registration for medicinal and medical products, consulting on marketing and product placement).
Giving training courses in ICH-GCP, and GLP.

Project Management

Extensive international project management experience in the chemical/pharmaceutical industry (R&D, Marketing, Business development).
Project Management of projects sponsored by the European Commission in Central- and Eastern Europe (Ukraine, Moldova), and Jordan.

Consulting

Management Consultant/Expert in the Healthcare/Life Sciences sector (pharmaceutical issues) for both governmental bodies/public institutions and the industry.
Consulting governmental bodies in the healthcare sector in Central- and Eastern Europe (public health, national drug policy, regulatory/legislative issues, and effective administration).
Preparing and implementation of GxP-compliant Quality Management Systems (QMS) following ISO 9001:2008