Pharmacovigilance regulatory requirements and technologies are constantly evolving. Volumes and complexity of safety data are ever-increasing. Safety data sources are shifting and the pace at which new technologies are emerging is accelerating. Organisational needs change over time and qualified resources are scarce. Mark Waring Pharmacovigilance Services has the expertise and experience to provide the external support you need in this dynamic environment: reliable, straightforward consulting on effective and compliant pharmacovigilance systems and processes, and effective hands-on operational support with your safety data collation, evaluation and reporting needs.
Mark Waring Pharmacovigilance Services is an independent consultancy that delivers high-quality and compliant pharmacovigilance solutions to clients in Europe and worldwide – on time and on budget. We support clinical trial sponsors with their clinical safety challenges and marketing authorisation holders of approved products. Building on over 20 years of industry experience, we offer external support for a broad range of services:
Maintenance of a PV system that is both regulatory compliant and proportionate to your organisation is a challenging task. Building on years of hands-on experience and in close co-operation with all stakeholders, we review your pharmacovigilance system, analyse gaps, and develop optimised process landscapes that meet your organisation's needs as well as regulatory expectations. We provide hands-on support with documentation of pharmacovigilance system components and processes, such as SOPs and Work Instructions. We also support maintenance of a compliant PSMF and consult you when planning for outsourcing of pharmacovigilance system components.
Let us help you understand your pharmacovigilance data and support you when pressing time lines need to be met. We evaluate your pharmacovigilance data systematically, comprehensively, scientifically and – if necessary – quickly. Our services range from strategic consulting on how to approach your safety questions to medical evaluation of ICSRs, literature reviews, safety data analysis and assessment, and preparation of full signal validation and evaluation reports.
RMPs can be complex, extensive documents and their compilation can be a challenging multidisciplinary task. Even where a standardised process for RMP development is in place, uncertainties about regulatory expectations for specific products are common and a robust, transparent process for classifying safety topics, determining adequate risk management measures and delivering a high quality document is often lacking. We can support you with identification, collection and assessment of the required information, and preparation of RMPs suitable for regulatory submission in Europe, and worldwide.
Let us write your PBRERs, PSURs, DSURs and AddCOs. We have extensive experience in authoring clinical and postmarketing period safety reports – both big and small and for a wide range of products. We provide individual report sections or full, ready-to-submit regulatory documents – on time and in line with all applicable regulations and your organisational needs.
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