According to AMG, the monitoring and reporting of side effects, interactions and cases of deaths related to an authorized medicinal products and study medication are for every pharmaceutical company a legal obligation.
To meet legal requirements, it takes a considerable effort with regard to staff, qualifications and experience.
Dr. Notghi Contract Research GmbH has been a reliable and competent partner for large and small national and international pharmaceutical companies for many years.
We provide standardized, reliable processes and through our support, we conserve your resources.
What we offer in drug safety:
⦁ Systematic literature research
⦁ Evaluation and coding of medical terms
⦁ Processing and reporting of individual cases (ICSR)
⦁ Legally required authorities reports: PSUR/PBRER, RMP, DSUR, (Annual-IND and PAER, USA)
⦁ Risk-benefit evaluations
⦁ Provision of a graduated plan officer according to §63a AMG or a legal representative
⦁ Acquisition of a product information hotline (24/7 if necessary)
You benefit from:
⦁ Experience in vigilance of medical devices
⦁ Provide a database system
⦁ Experienced workflow from research to report
⦁ Member of the Committee of ⦁ BPI
Conserve your resources through our support.
We offer a wide range of services in the field of drug safety for full- and part-service solutions.
Our experts will gladly advice you personally. We look forward to your call or your message.