With a global team of pharmacovigilance experts including experienced PV physicians, medics and access to our medical writing group, RLS offers a fully compliant and high-quality complete package of pharmacovigilance services. Our goal is to help our customers to meet the strict regulatory requirements, along with managing the risk-benefit profile of their products, to maximise product potential, whilst ensuring patient safety. From outsourcing of individual activities to the setup and management of an effective and efficient global pharmacovigilance system, RLS provides specific solution to the requirements of our customer’s organization and products. Our services are both global and European Union (EU) specific for both clinical trials and marketing authorization holders as well as manufacturers of medical devices.
Contents:
- Global and European Union (EU) Pharmacovigilance Services:
- Case Processing and Reporting
- Eu-Dra Vigilance
- Safety Data Management and Global Safety Database
- Signal Detection and Evaluation
- Risk Management
- Consultancy and Project Management and SOP Development
- Qualified Person for Pharmacovigilance (QPPV)
- Clinical Trial Pharmacovigilance
- Post Authorization / Marketed Products
- Medical Device Vigilance
