Pharmacovigilance systems Design and Consultancy

Our highly skilled specialists have many years of experience in both the operational and information management aspects of pharmacovigilance, which allows us to offer you a unique set of consulting services:


Detailed analysis of your current pharmacovigilance system and/or provider to identify changes that could be nessesary to meet the newest legislative requirements;

Implementing electronic and test reporting to European and U.S. Competent Authorities;

Turnaround & Crisis Management;

Working out and assistance with third-party Safety Agreements;

Design and implementation of tailored PV systems;

Preparation of important documents and protocols, e.g. SOPs;

Interactions with regulatory agencies on your behalf;

Guidance on product labelling, company core datasheets (CCDS) and company core safety information (CCSI);

Counselling on risk management;


Training / coaching in pharmacovigilance;

Independent assessment and interpretation of safety issues related to the product.