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. | |
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.