PHARMACOVIGILANCE & VIGILANCE
SAFETY AND VIGILANCE SUPPORT ACROSS THE PRODUCT LIFECYCLE
PHA FARMED provides pharmacovigilance and vigilance support for medicinal products, medical devices and cosmetics in European markets.
We support companies with safety management, regulatory reporting, quality documentation and coordination of specialised pharmacovigilance activities, tailored to the requirements of each product and market.
PHARMACOVIGILANCE
Safety support for medicinal products, including:
- Pharmacovigilance quality systems and SOPs
- Adverse reaction management
- Safety signal and risk management support
- PSUR and safety documentation
- EudraVigilance reporting support
- Audit and inspection readiness
MEDICAL DEVICE VIGILANCE
Post-market vigilance support for medical devices, including:
- Vigilance procedures and documentation
- Incident and safety information assessment
- FSCA and regulatory reporting support
- Trend and periodic reporting
- Literature monitoring
- Coordination with competent authorities
COSMETOVIGILANCE
Safety support for cosmetic products, including:
- Collection and assessment of undesirable effects
- Serious undesirable effect reporting
- Safety documentation
- Corrective and preventive measures
- Safety monitoring and evaluation
- Regulatory support under EU cosmetics requirements
Need safety or vigilance support for your products?
Let’s discuss the regulatory and operational support your portfolio requires.