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
![](https://comac-medical.com/wp-content/uploads/2020/02/Cardiovascular.jpg)
We have experience in the following therapeutic areas:
Gastroenterology
![](https://comac-medical.com/wp-content/uploads/2020/02/Gastroenterology.jpg)
We have experience in the following therapeutic areas:
Dermatology And Venereology
![](https://comac-medical.com/wp-content/uploads/2020/02/Dermatology.jpg)
We have experience in the following therapeutic areas:
Medical Devices
![](https://comac-medical.com/wp-content/uploads/2020/02/Medical_Device.jpg)
We have experience in the following therapeutic areas:
Endocrinology
![](https://comac-medical.com/wp-content/uploads/2020/02/Endocrinology.jpg)
We have experience in the following therapeutic areas:
Hematology
![](https://comac-medical.com/wp-content/uploads/2020/02/Hematology.jpg)
We have experience in the following therapeutic areas:
Immunology
![](https://comac-medical.com/wp-content/uploads/2020/02/Immunology.jpg)
We have experience in the following therapeutic areas:
Infectious Diseases
![](https://comac-medical.com/wp-content/uploads/2020/02/Infectious_Diseases.jpg)
We have experience in the following therapeutic areas:
Metabolic Diseases
![](https://comac-medical.com/wp-content/uploads/2020/02/Metabolic_Diseases.jpg)
We have experience in the following therapeutic areas:
Nephrology
![](https://comac-medical.com/wp-content/uploads/2020/02/Nephrology.jpg)
We have experience in the following therapeutic areas:
Neurology
![](https://comac-medical.com/wp-content/uploads/2020/02/Neurology.jpg)
We have experience in the following therapeutic areas:
Obstetrics And Gynecology
![](https://comac-medical.com/wp-content/uploads/2020/02/Gynecology.jpg)
We have experience in the following therapeutic areas:
Oncology
![](https://comac-medical.com/wp-content/uploads/2020/02/Oncology.jpg)
We have experience in the following therapeutic areas:
Lymphomas
![](https://comac-medical.com/wp-content/uploads/2020/02/Lymphomas.jpg)
We have experience in the following therapeutic areas:
Ophthalmology
![](https://comac-medical.com/wp-content/uploads/2020/02/Ophthalmology.jpg)
We have experience in the following therapeutic areas:
Pain Management
![](https://comac-medical.com/wp-content/uploads/2020/02/Pain_Management.jpg)
We have experience in the following therapeutic areas:
Pediatrics
![](https://comac-medical.com/wp-content/uploads/2020/02/Pediatrics.jpg)
We have experience in the following therapeutic areas:
Psychiatry
![](https://comac-medical.com/wp-content/uploads/2020/02/Psychiatry.jpg)
We have experience in the following therapeutic areas:
Rare Diseases
![](https://comac-medical.com/wp-content/uploads/2020/02/Rare_Diseases.jpg)
We have experience in the following therapeutic areas:
Respiratory Diseases
![](https://comac-medical.com/wp-content/uploads/2020/02/Respiratory-Diseases.jpg)
We have experience in the following therapeutic areas:
Women’s Health
![](https://comac-medical.com/wp-content/uploads/2020/02/Womens_Health.jpg)
We have experience in the following therapeutic areas:
Non-interventional Studies
![](https://comac-medical.com/wp-content/uploads/2020/02/Non-Interventional_Studies.jpg)