Pharmacovigilance
Surveillance and the notification of adverse effects of both licensed and trial medications are the duty of every pharmaceutical, generics and biotechnology company.
To comply with the regulatory requirements, organizations have to make a significant commitment in terms of qualified and experienced resources.
For many years Dr. Notghi Contract Research GmbH has been a reliable and competent partner for large and small national and international pharmaceutical companies and due to its long-standing experience ensures standardized, safe processes.
We help you conserve your valuable resources and reduce costs.
Strengths
- experience with handling of diverse databases
- established workflows from research to case reporting
- flexible, motivated and highly trained team
- absolute confidentiality, reliability and professionalism
Dr. Notghi Contract Research GmbH offers you a wide service range within pharmacovigilance for full and partial service solutions.
Services at a glance
- systematic literature surveillance
- evaluation and coding of medical terms
- data entry and ICSR-Handling
- regulatory reports: PSUR, RMP, DSUR, ASR, PASS (Annual-IND and PAER, USA)
- risk-benefit evaluation
Our experts will gladly provide you with personal consultation. We look forward to hearing from you! Contact
Extensive reporting requirements from July 2012
