Pharmacovigilance Services
QPPV And Local Contact Person Support
QPPV And Local Contact Person Support
QPPV And Local Contact Person Support
- We provide EU and UK QPPV support and local pharmacovigilance contact services to help you meet applicable requirements.
- We meet country-specific regulatory needs by offering LCPPV services
- Our support includes system oversight, Pharmacovigilance System Master File (PSMF) maintenance and liaison with regulatory authorities.
UK Pharmacovigilance Support
QPPV And Local Contact Person Support
QPPV And Local Contact Person Support
- We help you manage UK-specific pharmacovigilance requirements for marketed medicines and investigational products.
- Our support includes adverse reaction reporting through applicable MHRA submission systems, UK pharmacovigilance documentation and responses to MHRA queries.
- We also help your team assess changes to UK requirements and update relevant procedures and reporting processes.
Case Processing and Safety Reporting
QPPV And Local Contact Person Support
Case Processing and Safety Reporting
- We support the collection, assessment and processing of Individual Case Safety Reports (ICSRs), including data entry, medical review and submission. We help you manage reporting timelines and maintain consistent case quality.
Pharmacovigilance Services
Case Processing and Aggregate Reporting
Case Processing and Aggregate Reporting
Case Processing and Aggregate Reporting
- We prepare and support the submission of periodic safety reports, including Periodic Safety Update Reports (PSURs). Our approach brings together relevant safety information to support the ongoing evaluation of your products’ benefit–risk balance.
Risk Management Plans (RMPs)
Case Processing and Aggregate Reporting
Case Processing and Aggregate Reporting
- We develop, review and update Risk Management Plans (RMPs) to reflect your products’ safety profiles and applicable requirements.
- We support the planning and documentation of pharmacovigilance and risk-minimisation activities.
Signal Detection and Management
Case Processing and Aggregate Reporting
Signal Detection and Management
- We review safety information to identify and assess potential signals.
- We support signal validation, evaluation and documentation, helping your team determine appropriate next steps.
Pharmacovigilance Services
Literature Monitoring
Pharmacovigilance Systems and Inspection Readiness
Pharmacovigilance Systems and Inspection Readiness
We monitor relevant scientific and medical literature for reportable cases and emerging safety information. Our services support local and global literature review, assessment and documentation.
Pharmacovigilance Systems and Inspection Readiness
Pharmacovigilance Systems and Inspection Readiness
Pharmacovigilance Systems and Inspection Readiness
We help develop and maintain pharmacovigilance procedures, assess system gaps and prepare teams for audits and inspections.
Our support includes corrective and preventive action planning and follow-up.
Training and Ongoing Support
Pharmacovigilance Systems and Inspection Readiness
Training and Ongoing Support
We provide tailored Good Pharmacovigilance Practices (GVP) training to help your team understand its responsibilities and apply procedures consistently.
We also support changes to your processes as your business and regulatory requirements evolve.