Product Safety Management
PharmacoVigilance
ProductLife offers a complete range of pharmacovigilance and medical monitoring services, with a unique ability to tailor our services directly to your needs. We have global capabilities and work within all applicable regulatory and international requirements.
Clinical Drug Safety Services:
- Full Serious Adverse Event case management (SAE processing, SUSAR submissions)
- Developmental Safety Update Reports (DSURs)
- Medical Monitoring
- EudraVigilance registration and maintenance
Post Marketing Drug Safety Services:
- Provision of Qualified Person for EudraVigilance (QPPV)
- Pharmacovigilance systems management:
- Literature review
- Pharmacovigilance System Master File
- Management and reporting of adverse reactions (Individual Case Safety Reports)
- Periodic Safety Update Reports & Risk Management Plans
- eXtended EudraVigilance Medicinal Product Dictionary
Our team of specialists can help you in outsourcing parts or all of your pharmacovigilance tasks. We can provide small to mid-sized pharmaceutical companies the benefits of a fully-staffed pharmacovigilance unit.
Safety Database
With our industry standard fully validated safety database system which is E2B and 21 CFR Part 11 compliant, we can produce ICSRs, monthly line-listings, annual safety reports and periodic safety update reports.
We also have experience working with a range of client’s safety database (via remote access).
Clinical Drug Safety
- Individual Case Safety Reports processing for Serious Adverse Events (SAEs)
- Medical Monitoring and Medical assessments of SAEs
- Un-blinding and global regulatory reporting
- Experienced in working with a range of CROs while holding the global safety database
Post Marketing Drug Safety
- Qualified person for Pharmacovigilance for our UK office
- ICSR assessment, triage and processing, as well as follow-up requests
- Global regulatory reporting
- Systematic Literature Searches & Review
- Creation and management of Pharmacovigilance System Master Files
Medical Writing
Preparation of dossiers and reports for submission to authorities:
- Annual Safety Reports such as DSURs & PSURs
- PharmacoVigilance System Master Files
- Risk Management Plans
Audits & Training
Our experienced staff provide pharmacovigilance training and can perform onsite/offsite audits of your pharmacovigilance systems, review SOPs and compliance to the new pharmacovigilance regulations.
Medical Device Safety
- Medical device vigilance including clinical investigations and Post Marketing Clinical Follow-up Studies
With our wide experience and knowledge we offer the complete solution. We have the required skills to monitor the safety of your product from the clinical stage to marketing approval and beyond, covering clinical trials, post marketing studies, spontaneous reports and literature searches.
Latest News
Friday 21.06.2013
ProductLife invites you to its next Business Breakfast: Challenges & complexity of Qualified Person for Pharmacovigilance
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Friday 17.05.2013
ProductLife invites you to its next Business Breakfast: Quality by Design
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Wednesday 24.04.2013
ProductLife attends Regulatory Information Management in Cologne
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