Pharmacovigilance Services
QPPV Support
National Contact Person For Pharmacovigilance
National Contact Person For Pharmacovigilance
- We provide experienced QPPVs to oversee your pharmacovigilance system, ensuring compliance with EU and UK regulations.
- Our QPPVs manage safety reporting, maintain Pharmacovigilance System Master Files (PSMF)
- And act as a 24/7 liaison with regulatory authorities.
National Contact Person For Pharmacovigilance
National Contact Person For Pharmacovigilance
National Contact Person For Pharmacovigilance
- We meet country-specific regulatory needs by offering LCPPV services
- Ensuring compliance with local legislation in EU and EEA.
- And regions outside the EU
Brexit Support
National Contact Person For Pharmacovigilance
Brexit Support
- Case management using MHRA portal
- Submission of ADRs to competent authority.
- Support with clinical trial products and commercial products
- Regulatory support as required
Pharmacovigilance Services
Case Processing and Aggregate Reporting
Case Processing and Aggregate Reporting
Case Processing and Aggregate Reporting
- Our team handles Individual Case Safety Reports (ICSRs), ensuring timely and accurate data entry, medical review, and expedited reporting.
- We also prepare and submit periodic aggregate reports (e.g., PSURs) in compliance with global regulatory standards.
Risk Management Plans (RMPs)
Case Processing and Aggregate Reporting
Case Processing and Aggregate Reporting
- We design, implement, and update RMPs to identify and mitigate risks associated with your products
Signal Detection and Management
Case Processing and Aggregate Reporting
Signal Detection and Management
- Leveraging advanced analytics and expert oversight.
- We identify, evaluate, and address emerging safety signals to protect patients and maintain regulatory compliance.
Pharmacovigilance Services
Global Literature Monitoring
Inspection Readiness and Audits
Inspection Readiness and Audits
- We conduct regular surveillance of scientific and medical literature to identify potential safety concerns or adverse reactions related to your products.
Inspection Readiness and Audits
Inspection Readiness and Audits
Inspection Readiness and Audits
- NKpharma supports you in preparing for regulatory inspections and conducts thorough internal audits to ensure your systems are always compliant.
GxP Training and Support
Inspection Readiness and Audits
GxP Training and Support
- Our tailored training programs help your team stay informed and compliant with Good Pharmacovigilance Practices (GVP).