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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:
Cardiology
We have experience in the following therapeutic areas:
Gastroenterology
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:
Dermatology And Venereology
We have experience in the following therapeutic areas:
Medical Devices
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:
Endocrinology
We have experience in the following therapeutic areas:
Hematology
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:
Immunology
We have experience in the following therapeutic areas:
Infectious Diseases
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:
Metabolic Diseases
We have experience in the following therapeutic areas:
Nephrology
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:
Neurology
We have experience in the following therapeutic areas:
Obstetrics And Gynecology
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:
Oncology
We have experience in the following therapeutic areas:
Lymphomas
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:
Ophthalmology
We have experience in the following therapeutic areas:
Pain Management
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:
Pediatrics
We have experience in the following therapeutic areas:
Psychiatry
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:
Rare Diseases
We have experience in the following therapeutic areas:
Respiratory 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:
Women’s Health
We have experience in the following therapeutic areas:
Non-interventional Studies
We have experience in the following therapeutic areas:
Non-interventional Studies
SUBMIT RFP