QUALITY MANAGEMENT (QM)
- QM-systems according to ISO 9001
- QM in pharmacovigilance according to the European “Guideline on Monitoring of Compliance with Pharmacovigilance Regulatory Obligations and Pharmacovigilance Inspections“
- QM in pharmaceutical distribution according to „Good Distribution Practice“
- Internal audits
- Vendor-/ Partner Audits
- Pharmacovigilance Audits
- Preparation and Follow-up of Pharmacovigilance Inspections
PHARMACOVIGILANCE
- Qualified Person for Pharmacovigilance in the EU
- Commissioner for the Graduated Plan according to German Drug Act
- 24 hours preparedness for SAE reporting in clinical trials
- Complete case processing, including MedDRA-coding, narrative-preparation and authority submission (paper and electronically)
- Pharmacovigilance database
- Literature research
- Preparation of pharmacovigilance and risk management plans
- Training
MEDICAL-SCIENTIFIC SERVICES
- Medical monitoring in clinical trials
- Literature research and analysis
- Scientific assessment reports
- Processing of scientific publications for marketing and sales purposes
- Medical translations
- Information responsible according to German Drug Act