Product Safety

  • Regulatory Solutions
  • Product Safety
  • Pharmaceutical Development and Quality
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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.

More information

Latest News

ProductLife Group Expands German Operations with Acquisition of Kohne Pharma.
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Tuesday 02.12.2014
2–3 December 2014, Drug Information Association 15th Conference on European Electronic Document Management (eDM), Berlin
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Thursday 13.11.2014
13 November, PLG Evolve Webinar: Enhancing the Affiliate Relationship through Strategic Approaches to RIM
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Friday 31.10.2014
31 October, PLG Evolve Webinar and Petit Déjeuner: Industry Trends and Developments on RIM
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