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Pharmacovigilance

Pharmacovigilance

A full range of pharmacovigilance services is available for medicines and medical devices, both during clinical development and post-marketing

Meeting your post-marketing pharmacovigilance, clinical study safety, or device vigilance obligations is a key requirement for your business.  In this section you can see how Wainwright Associates can help, whether it be the day-to-day handling of safety-related information on your behalf, providing consultancy for the safety aspects of your clinical trials/investigations, or conducting audits and training.

Sponsors of clinical studies and holders of Marketing Authorisations for medicinal products are required to continuously monitor the safety of trial subjects and patients and meet ever more stringent regulatory requirements.

In addition, the Post-marketing Surveillance and Vigilance reporting requirements for medical devices have recently been formalised with the implementation of a more structured EU-wide vigilance system.

Whether you are planning a new Marketing Authorisation Application, have new or established medicinal products on the market, or are working with investigational medicinal products or medical devices, the team at Wainwright Associates have the experience  and knowledge to assist you in meeting your pharmacovigilance obligations.

We will work with you to suit your requirements, whether it be on an ongoing basis or to address a  single specific need.