Historique

AXPHARMA is a Clinical Service Organisation (CSO). Since 2001, it has been the European leader in the complete, partial or temporary outsourcing of pharmacovigilance services, including a 24/7 medical information hotline (clinical support centre). Most of its activities are in Europe, principally in France, the Benelux and Switzerland.

Thanks to its significant expertise in this field, AXPHARMA’s clients include many European pharmaceutical companies as well as the subsidiaries of AmericanJapanese and Indian laboratories.

AXPHARMA’s all-round knowledge on problems involving pharmacovigilance and medical information mean that it can rapidly put together crisis management teams to respond to clients’ needs.

AXPHARMA’s expertise covers all therapeutic classes, guaranteeing high-quality services.


Edito

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 In a world that is ever more demanding with regard to healthcare safety, regulation has now gone far beyond the traditional pharmacovigilance applicable to human medicines. Regulatory vigilance now extends to such spheres as medical devices, cosmetics and even nutrition.Clear lines have been drawn by new legislative frameworks and no “responsible company” could risk transgressing them.
In this context, the authorities’ desired goals—of improving healthcare systems whilst reinforcing the trust placed in them by both healthcare professionals and the public—require that procedures for the detection of potential adverse effects are of the highest quality. As such, proper accreditations are becoming essential, notably from the Drug Information Association and other global bodies.

With risk/benefit monitoring now taking place throughout product lifecycles, vigilance is going through profound change; quality assurance in inextricably linked to this. Due to the recent period of significant regulatory change, pharmacovigilance managers will henceforth have to take a leading role throughout product lifecycles.

I started AXPHARMA 15 years ago. Thanks to the international expertise in pharmacovigilance that its staff have developed, AXPHARMA not only accompanies its clients in managing standard vigilance and reporting, but also supports them in the complex management of cases involving authorities such as the EMA. The management of other types of vigilance, such as for medical devices or cosmetics, now requires similar expertise, as does monitoring of the medical and pharmaceutical information distributed to patients and healthcare professionals. AXPHARMA even provides a 24-hour medical information hotline manned by a specialised, experienced team of professionals.

As the market leader in its fieldAXPHARMA truly offers a 360° perspective on vigilance, involving the relevant audits, consultancy services and specially adapted training programmes.

On the ground, my wish is for AXPHARMA to be a company that remains close to its customers and attentive to their needs. In this way, AXPHARMA will be able to help them anticipate and adapt to regulatory changes that benefit patients; instead of suffering, their businesses will remain sustainable.

AXPHARMA is looking forward to the challenges of building interdependence between the different participants in the field of healthcare, sharing information using standardised processes and innovating in reaction to our clients’ problems.