Signal Detection and
PDS understands that signal detection and management activities are essential steps for our client’s proactive pharmacovigilance.
PDS can provide you with a bespoke signal detection/signal management service which can be applied throughout your products life cycles, ensuring compliance with international regulatory requirements including EU GVP Module 1X and FDA Good Pharmacovigilance Practices.
RMPs and REMs (RISK MANAGEMENT PLANS and RISK EVALUATION & MITIGATION STRATEGIES)
The team here at PDS are skilled in writing Risk Management Plans (RMPs) and Risk Evaluation & Mitigation strategies (REMs), in line with the EU GVP Module V – Risk Management Systems requirements and FDA guidance for developing an effective REMs strategy.
PDS can provide you with a service for just one single RMP/REMS or all of your RMPs/REMS, we ensure we tailor make our service to meet your actual requirements and we further ensure we deliver a quality cost effective service.
Call us now on +44(0) 1476 512395 to discuss your project with one of our team.