Clinical Research
Complete managing and organizing of clinical studies phases I – IV (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):
- Managing the clinical development part within the drug development process
- Monitoring and auditing of clinical studies in particular in Central- and Eastern Europe according to ICH-GCP, GLP and GPP.
- Preparing and maintaining of the required study documentation.
- Reporting and Medical writing.
- Providing training courses in ICH-GCP, GLP and Study management
- (ICH)-GCP Auditing
Creating competitive product portfolios; Business Intelligence analyses
Developing product portfolio based marketing and sales strategies