Pharmacovigilance EU & MENA
More than ever, pharmacovigilance is a key issue in regulated markets. Safety and legislation are in the core of our philosophy. An experienced and fully dedicated team is always available for you and your patients in Baupharma.
- PSMF
- Creation
- Review/Update
- EU QPPV
- Local QPPVs
- Local Safety Officers
- Drug Safety Officers
- Literature search
- Global
- Local
- Data Management
- PV Database
- ICSR
- XEVMPD
- IDMP
- Audits
- Inspections Support
- Assistance in Critical Findings
- CAPA preparation
- Pharmacovigilance Training
- Pharmacovigilance Intelligence
If you are interested in further information, get in contact with us at phv@baupharma.com
Medical Writing
In order to register a product or be compliant with current requirements and legislation, you need to have your documentation ready and up-to-date. Our writers, with medical and pharmaceutical background, are here to assist you:
- Environmental Risk Assessment
- PSMF
- Risk Management Plan
- Nonclinical Overview & Summary
- Clinical Overview & Summary
- PSURs
- DSURs
- SOPs
- CAPAs preparation
If you are interested in further information, get in contact with us at phv@baupharma.com