Solutions
Safety and Pharmacovigilance
Short overview of the services our team offers in drug safety management is shown below:
- Clinical trials safety management
- Preparation of SMA
- Full processing of individual cases
- Periodic reports preparation (line listings, DSUR)
- Post marketing activities
- Literature search and review
- Product complaint managements
- PSMF Preparation and Maintenance
- Risk-Management, crisis management & consulting (preparation of RMP)
- Qualified Person for Pharmacovigilance (QPPV) in Europe
- Local (PV) contact person
- Aggregate periodic reporting (PSUR, etc.)
- Safety Database hosting with electronic regulatory reporting in EudraVigilance
- Global interaction with and reporting to Competent Authorities
- Generation of CIOMS Reports
- Product Reporting within XEVMPD
Therapeutic Areas
We have experience in the following therapeutic areas:
Cardiology
We have experience in the following therapeutic areas:
Gastroenterology
We have experience in the following therapeutic areas:
Dermatology And Venereology
We have experience in the following therapeutic areas:
Medical Devices
We have experience in the following therapeutic areas:
Endocrinology
We have experience in the following therapeutic areas:
Hematology
We have experience in the following therapeutic areas:
Immunology
We have experience in the following therapeutic areas:
Infectious Diseases
We have experience in the following therapeutic areas:
Metabolic Diseases
We have experience in the following therapeutic areas:
Nephrology
We have experience in the following therapeutic areas:
Neurology
We have experience in the following therapeutic areas:
Obstetrics And Gynecology
We have experience in the following therapeutic areas:
Oncology
We have experience in the following therapeutic areas:
Lymphomas
We have experience in the following therapeutic areas:
Ophthalmology
We have experience in the following therapeutic areas:
Pain Management
We have experience in the following therapeutic areas:
Pediatrics
We have experience in the following therapeutic areas:
Psychiatry
We have experience in the following therapeutic areas:
Rare Diseases
We have experience in the following therapeutic areas:
Respiratory Diseases
We have experience in the following therapeutic areas:
Women’s Health
We have experience in the following therapeutic areas:
Non-interventional Studies