We help our clients plan and establish organisation-wide Drug Safety Strategies to meet regulations and improve patient outcomes.
A comprehensive Drug Safety Strategy is of vital importance to Pharmaceutical organisations
We support clients with a complete set of Drug 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 support carefully planned safety strategies that fit the short-term and long-term business plan of your organization. We also help clients conduct detailed analysis of their current state and gap analysis in terms of people, process and technology. This is all underpinned by strict adherence and attention to the diverse regulation requirements your organisation faces.
A robust Pharmacovigilance strategy requires expertise in medicine, regulatory affairs, and technology. We offer strength and robustness in each of these domains at both an individual and holistic level to produce outstanding results. We can support you in the following areas:
Processes and SOPs (standard operating procedures).
Individual case study report capture and processing.
Signal detection and assessment.
Explore more of our Clinical 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.
With a team of over 190 PV experts we produce high quality and compliant safety reports, including PBRERs, PSURs, DSURs, RMPs and Safety Evaluation Reports to name but a few.
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.