Hilbrans Consulting
Contents
About
HilbransConsulting GmbH has considerable international experience in various aspects of medical services for the pharmaceutical industry and is familiar with global aspects and cultural differences in these fields. As we are based in Germany, the services we offer are mainly focussed on EU countries. We have gathered experience in working with a broad range of pharmaceutical companies including
- Global pharmaceutical companies
- Biotechnology companies
- Contract Research Organisations
Thus we can provide cost-effective and flexible services tailored to our clients' needs. We are ready to support limited internal resources with respect to routine business as well as to assist in special situations and challenges. At HilbransConsulting GmbH, we are committed to ensuring that our work is timely and of the highest standard. Founded by Dr. Jutta Hilbrans in 2006.
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| Type | Public / Private |
Services
- Pharmacovigilance
- Clinical Research
- Quality Management
Pharmacovigilance
Services offered by HilbransConsulting include:
- Advice on regulatory requirements/ regulatory compliance
- Implementation of pharmacovigilance systems according to Volume 9A
- Processing and medical evaluation of single case reports (SAE/ICSR)
- Generation of periodic safety reports (Annual Safety Reports, PSURs)
- Generation of EU Risk Management Plans
- Literature search, review and evaluation
- Advice on safety labelling (SmPC/Core Safety Information)
- Assistance with safety agreements in contractual relationships
- Support of safety data base implementation
- Pharmacovigilance training
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