Our senior personnel have many years of experience in both the operational and database management aspects of pharmacovigilance. We can offer the following consulting services:

Evaluation of your current pharmacovigilance system and/or provider with the aim of identifying changes required to meet current regulatory and legal requirements;

Preparation for electronic reporting and test reporting to European Competent Authorities;

Crisis Management;

Training in pharmacovigilance;

Preparation and assistance with third-party Safety Agreements;

Design and implementation of pharmacovigilance systems;

Preparation of essential documents and procedures, e.g. SOPs;

Advice on product labelling and interactions with regulatory agencies;

Advice on company core datasheets and company core product information;

Advice on risk management;

Independent analysis and interpretation of product safety issues.