At Jeyflex, we offer comprehensive Medical Writing and Translations services, covering a range of critical documents such as Patient Information Leaflets (PILs), Summary of Product Characteristics (SmPC), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Standard Operating Procedures (SOPs), and Pharmacovigilance System Master Files (PSMFs).
By outsourcing your medical writing and translation requirements to Jeyflex, you benefit from
- Effective Communication: We ensure efficient communication between all stakeholders, fostering transparency and understanding.
- Robust Quality Management: Operating within a streamlined and robust Quality Management System overseen by experienced professionals, including our Qualified Person for Pharmacovigilance (QPPV), we maintain the highest standards of quality and compliance.
- PSMF Expertise: Our team can create and maintain both core and local Pharmacovigilance System Master Files (PSMFs), ensuring complete compliance with specific local regulations and Global Pharmacovigilance (GPV) guidelines, enhancing your system’s visibility and compliance readiness.
- Risk Mitigation: For Marketing Authorization Applicants (MAAs) without an in-house QPPV, our outsourced QPPV services can effectively mitigate resource risks, ensuring preparedness for various regulatory outcomes.
- Comprehensive Support: Whether it’s the implementation of a new pharmacovigilance system, a system transfer, or the need for Local Persons for Pharmacovigilance (LPPV) and Local Safety Officer (LSO) services, our experienced team is equipped to guide you through all required pharmacovigilance activities and regulatory compliance requirements.
Optimizing Your Medical Writing and Translation Processes
With a dedicated focus on precision and compliance, our Medical Writing and translation services are designed to meet your specific regulatory requirements while ensuring clarity and accuracy in all medical documents and translations. By entrusting your medical writing and translation needs to Jeyflex, you can access a dedicated team of experts committed to delivering exceptional results.
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Contact us today to learn more about how our Medical Writing and Translations services can elevate your pharmacovigilance processes and ensure seamless compliance with global standards and local regulations.
Our solutions are tailored to meet your unique needs and requirements, whether you’re a small startup or a large multinational corporation. We offer a range of services, including, consulting, training, and auditing, to help you ensure that you are complying with relevant regulations and laws, and to minimize the risk of non-compliance.