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

Risk Management Plans (RMPs)

Additional Risk Minimization Measures (aRMM)

Medical Information Call Center (MICC) Support

US Risk Evaluation and Mitigation Strategies (REMS)

Targeted Follow-Up Questionnaires (TFUQs)

MAH/Applicant Support

Stakeholder/Local Affiliate Training
ARTICLE
Automation of literature search and review
ARTICLE
Gen AI in PV and Regulatory Affairs
CASE STUDY
PV Safety Benefit Risk Management Optimization and Integration
Extensive Experience in Managing Efficient Clinical Trials

Skilled professionals with deep expertise across multiple therapeutic areas

Customizable to meet your specific needs

Delivering value without compromising quality

Leveraging the latest tools to enhance risk management