A flexible partner to support your in-house PV teams.
We free up in-house staff to help them make quicker and safer decisions
Our team of over 190 Pharmacovigilance experts have extensive knowledge and capabilities in PV Safety report writing.
We produce high quality and compliant safety reports including PBRERs, PSURs, DSURs, RMPs and Safety Evaluation Reports.
Our Complete Range of PV Services
Pharmacovigilance Writing, including complete authoring of PV aggregate reports as well as managing the complete PV report process through to hand off for submission.
Medical evaluation activities. We have a team of skilled medics with extensive PV experience who are able to support clients with medical evaluation related activities including ICSR medical review, signal detection activities, risk minimisation and risk management.
Single Case Processing. We partner and provides support across the full span of single case processing, including triage, medical literature monitoring, quality review and expedited reporting.
Coding Support, including MedDRA coding, xEVMPD and IDMP.
Quality Assurance, including support with audits and inspection readiness.
Partners of choice
We are currently involved in managing safety report writing for multiple top 20 Pharmaceutical clients and in some cases we are the sole providers working extensively as their partner of choice over the last few years.
Our successes with these key strategic PV writing programs have been achieved by:
Ensuring our safety writing processes are tailored to each client, minimising client effort while maximising quality and timely delivery.
Ensuring delivery to specification is managed through data-driven performance assessment and well defined and measurable key performance indicators.
Assurance of quality. We pride ourselves in delivering high quality outputs and these are achieved through a robust internal QC and medical review process as well as optimising the process when the time demands.
Ensuring critical requests such as those from Health Authorities are given the urgency which they demand and are dealt with in an expedited manner.
Always understanding whether there is potential for process optimisation and working with our clients to achieve this optimisation.
State of the art report trackers and tools to guide the teams for action oriented decisions and developing best practices.
Explore more of our services
We share our client’s commitment to achieving successful patient outcomes whilst ensuring patient safety. Our market leading integrated services support all your pre and post approval activities.
We support clients with a complete set of Safety Strategy services. Whether that means helping clients establish a global PV system, sourcing safety expertise, ensuring standard global SOPs, or solving any other challenge your organisation faces. Each company has its own set of unique challenges – we recognise this and offer tailored solutions to meet your needs.
We have an unmatched global Regulatory Maintenance and operations capability to deliver exclusive end-to-end solutions for the life cycle maintenance of your product portfolio.