Pharmacovigilance
Communication with National Competent Authorities
When Competent Authorities have questions about the safety of your products, they require answers fast. DADA can help you in understanding the questions, identifying the necessary resources for the response, develop the strategy and contribute to, write, or review and comment on the response document.
To prevent is better than to cure and DADA has all the necessary procedures in place to ensure early identification of potential safety concerns and their effective management through adequate signal evaluation and communication at the time of safety findings.
Services
Other services in Pharmacovigilance
- Audits
- EU Qualified Person for Pharmacovigilance (QPPV)
- Expedited reporting
- Global and local literature screening and review
- ICSR/SUSAR processing
- Inspection readiness
- Local (QP)PV support and AE/MI/PQC processing
- Organisation set-up and changes
- Periodic safety reporting
- Post-Authorisation Safety Studies (PASS)
- PV SOPs and other controlled operating instructions
- PV System Master File (PSMF)
- Risk Management Plans (RMPs)
- Safety Data Exchange Agreements (SDEAs)
- Signal detection and evaluation – benefit/risk assessment in safety review meetings
- Training in pharmacovigilance
- Veterinary PV support
- XEVMPD population and maintenance
Business hours
- Monday – Friday
- 9am – 5pm
- Saturday
- Closed
- Sunday
- Closed