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

Clinical Trials

Pharmaceutical

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Panacea

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