Pharmacovigilance and Regulatory Affairs

Pharmacovigilance

Understanding pharmacovigilance regulations and requirements, access to a wide range of services, and a senior exert team are repeatedly highlighted as an essential criterion when client select Xendo pharmacovigilance as their flexible service provider. Working on global level, we understand international requirements, and being consistently quality driven and customer focused has led to a proven track record of meeting or exceeding clients expectations. We are also regularly asked to lecture or moderate at international seminars and symposia as experts in the field.

From the outset, we have been a full service provider for Pharmacovigilance due to sound quality management systems, all activities conducted for and on behalf of clients are ensured to be in line with applicable standards.

Regulatory Affairs

We help to navigate the scientific and regulatory requirement and provide high level regulatory affairs services in all phases of product life cycle. From early stage development to marketing authorization and post approval requirements. We provide a complete range of services needed for successful preparation, submission and support of pharmaceutical, bio-pharmaceutical and medical device dossiers.

We are experienced partners to facilitate the contact with health authorities during the development and maintenance phase of your product.