MRT Pharma provides the services to comply with EMEA regulations for drug safety and pharmacovigilance, including assessing reports based on the seriousness of adverse events.
- Comprehensive Case Management
- Data entry, narrative generation, and quality-control
- MedDRA Coding of adverse events (including regular supversioning)
- Follow-up case processing
- Case closure
- Periodic Safety Reports
- Reconciliation of Adverse Events with business partners and Quality Assurance group
- Review of Global Safety Agreements
- Literature review
- Risk Management
Specialized pharmacovigilance services
- Periodic Safety Update Reports (PSUR)
- Processing of individual cases
- Integrated safety summaries
- Company Core Data Sheet Generation and Maintenance
- Development and testing of products on the market
- Security and surveillance programs
- Development of risk reduction and management plans
- Development of the risk assessment and mitigation programs (REMS)
- Risk Audit Preparation
- Review of data encoding and verification of source documents in proportion to the percentage of adverse reaction reports
Our goal is to help your company to legal requirements and regulatory checks and meet expectations.
A broad and growing selection of services to rely on us for all of us pharmacovigilance tasks incurred by the marketing authorization holder.
Whether all pharmacovigilance tasks entrusted to us or in some cases, need support or advice, we are at your disposal.
If you’re not sure which of our services to your company needs, please contact us and we will be happy to look for the best solution for you.
We perform any or all of pharmacovigilance activities on behalf of your company willing.