Pharmacovigilance Outsourcing

Looking to streamline your pharmacovigilance processes and ensure regulatory compliance while reducing operational costs?

Our Pharmacovigilance Outsourcing Service offers a comprehensive solution tailored to meet your specific needs. 

With our expertise and dedication to regulatory compliance and patient safety, we offer a range of tailored solutions to meet your pharmacovigilance needs effectively.

• Adverse Event Reporting: Timely and accurate reporting of adverse events, ensuring compliance with local and global regulatory requirements such as EDA, FDA, SFDA, and ICH guidelines.
• Case Processing and Management: Efficient case processing and management, including data collection, evaluation, and documentation of adverse events and product complaints.
• Signal Detection: Proactive signal detection and risk management activities to identify potential safety concerns and mitigate risks associated with pharmaceutical products.
• Aggregate Report Preparation: Preparation of periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs), and other aggregate safety reports to fulfill regulatory obligations.
• Literature Search: Comprehensive literature monitoring and review services to identify relevant safety information from scientific literature, regulatory sources, and medical databases.
• Regulatory Compliance Support: Guidance and support for regulatory submissions, inspections, audits, and compliance with pharmacovigilance regulations and guidelines.
• Quality Assurance and Auditing: Quality assurance oversight and auditing services to ensure the integrity, accuracy, and completeness of pharmacovigilance data and processes.
• Risk Minimization Strategies: Development and implementation of risk minimization strategies, including Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs).

• Expertise: Our team consists of experienced pharmacovigilance professionals with in-depth knowledge of global pharmacovigilance regulations and best practices.
• Flexibility: We offer flexible outsourcing solutions tailored to your specific pharmacovigilance needs and requirements.
• Scalability: Our services are scalable to accommodate fluctuations in workload and ensure timely delivery of pharmacovigilance activities.
• Cost-Effectiveness: Outsourcing pharmacovigilance activities to us can result in cost savings and operational efficiencies compared to in-house solutions.
• Commitment to Quality: We are committed to delivering high-quality pharmacovigilance services that prioritize patient safety and regulatory compliance.

 Partner with us to streamline your pharmacovigilance processes, enhance drug safety monitoring, and ensure compliance with regulatory requirements. 

Contact us today to learn more about our Pharmacovigilance Outsourcing Service and how we can support your pharmacovigilance needs effectively.