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

Life Sciences

Medical Devices

Pharmaceutical

Panacea

Panacea's headquarters in Douglas, Isle of Man

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