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:
Post Marketing Drug Safety Services:
- Literature review
- Pharmacovigilance System Master File
- Management and reporting of adverse reactions (Individual Case Safety Reports)
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.
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).
Post Marketing Drug Safety
Preparation of dossiers and reports for submission to authorities:
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
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.
ProductLife invites you to its next Business Breakfast: Challenges & complexity of Qualified Person for Pharmacovigilance
ProductLife invites you to its next Business Breakfast: Quality by Design
ProductLife attends Regulatory Information Management in Cologne