Panacea

Panacea provides regulatory & pharmacovigilance services to companies at the clinical trial, Marketing Authorisation application and the post-authorisation phases; we also offer veterinary PV and medical device vigilance services. Panacea is responsible for Marketing Authorisations (MAs) in every EU country; we also have experience of inspections from the MHRA, the IMB, and the FDA. We are a flexible and responsive team of professionals and can help clients in a variety of ways; whether it’s a one-off task, a fixed term project (large or small) or a continuous relationship over several years. We know that each client is different; each has a specific budget, timescale, and objective, and we do everything we can to ensure that all objectives are achieved. A dedicated quality function underpins everything we do. We provide the full suite of PV services including; EU Qualified Person for Pharmacovigilance (QPPV) * Deputy QPPV provision * Safety Physician provision * Pharmacovigilance System Master File (PSMF) – prep and maintenance * Risk Management Plans (RMP) – prep and maintenance * Medical Information provision* ICSR submission via EVWEB * Safety Data Exchange Agreements (SDEA) set up and maintenance. Well regarded by regulators and industry commentators, we are creative and good at problem-solving – always striving for a better way of doing things. We like to think we are easy to do business with and are always ready to talk. For further information visit www.panaceapharmaprojects.com