Pharmacovigilance Services
                                     Mark Waring

Our services

Mark Waring Pharmacovigilance Services provide reliable advice and effective operational support to pharmaceutical companies to help accomplish their clinical and post-marketing pharmacovigilance goals. Deliverables range from strategic planning to preparation of ready-to-submit regulatory documents. Find out more about our services on the following pages:


 

Pharmacovigilance system and process consulting

Gap analysis, conceptualisation and documentation of pharmacovigilance system components and processes that meet both, your organisation's needs as well as regulatory expectations.



Safety data assessment and signal evaluation

Strategic advice and structured assessment of your pharmacovigilance data, and preparation of signal evaluation reports.



Risk management plans

Support with identification, collection and assessment of the required information, and preparation of RMPs suitable for regulatory submission in Europe, and worldwide.



Periodic safety reports and medical writing

Individual report sections or full, ready-to-submit regulatory documents - in line with all applicable regulations and your organisational needs.



Pharmacovigilance training and coaching

On-site pharmacovigilance training and coaching tailored to your needs.

We know that no two clients are alike. Our solutions are always tailored to your specific expectations. As a freelance consultanty, we are flexible, fast and cost-effective. Contact us to discuss your needs.