Ensuring the safety of your medicinal products with effective Risk Management Services

Effective risk management is crucial for the safety of medicinal products, ensuring that all serious risks are appropriately managed and that products are safely administered with suitable measures. At Navitas Life Sciences, we specialize in providing comprehensive risk management services to safeguard patient health and compliance with regulatory standards.

Outsource your Risk Management needs

Navitas Life Sciences is committed to identifying, characterizing, preventing, and mitigating risks for your products. Our team of subject matter experts and experienced physicians delivers end-to-end services for preparing Risk Management Plans (RMPs) for the EU, UK, India, and other ROW countries. Our expertise spans all therapeutic classes, including Oncology, CNS, CVS, and psychiatry. We support marketing authorization applicants and holders in meeting all regulatory requirements, ensuring continuous maintenance of the Risk Management Plan. Our comprehensive, customizable, fully-validated, and cost-effective solutions are further supported by best-in-class technologies.

Our comprehensive Risk Management Services include

aRMM Tracking and Effectiveness Assessment

aRMM Tracking and Effectiveness Assessment

Monitoring and evaluating the impact of risk minimization measures
Risk Management Plans (RMPs)

Risk Management Plans (RMPs)

Compilation, writing, and updates
Additional Risk Minimization Measures (aRMM)

Additional Risk Minimization Measures (aRMM)

Implement educational tools, HCP training, and registries via web portal
Medical Information Call Center (MICC) Support

Medical Information Call Center (MICC) Support

Handling enrollment queries, ADR/pregnancy reporting, and follow-ups.
US Risk Evaluation and Mitigation Strategies (REMS)

US Risk Evaluation and Mitigation Strategies (REMS)

Development and updates
Targeted Follow-Up Questionnaires (TFUQs)

Targeted Follow-Up Questionnaires (TFUQs)

Ensuring thorough follow-up
MAH/Applicant Support

MAH/Applicant Support

Oversight process build-up
Stakeholder/Local Affiliate Training

Stakeholder/Local Affiliate Training

Comprehensive training for all involved parties

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Extensive Experience in Managing Efficient Clinical Trials

Expert Team
Skilled professionals with deep expertise across multiple therapeutic areas
Flexible Solutions
Customizable to meet your specific needs
Cost Effective
Delivering value without compromising quality
Cutting-Edge Technology
Leveraging the latest tools to enhance risk management

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