Support communication with authorities
As an experienced sparring partner we know how to develop, coordinate and execute observational studies in response to requests from authorities such as the European Medicines Agency (EMA). All new medicines must be authorised before they may become available on the European market. This authorisation can be achieved through the centralised or the national route. For either route PHARMO can provide essential information to help build your application. Requests from the authorities do not end after authorisation. When you are asked to deliver post-marketing information to the authorities, the PHARMO Database Network is an extensive source of information. For more material on post-authorisation studies, click here.
The quality of our research meets the rules and regulations of the EMA. Our internal standardised procedures and quality guidelines are in accordance with the ENCePP Guide on Methodological Standards in Pharmacoepidemiology and the ENCePP Code of Conduct to guarantee high quality services. This Code should not be considered as a stand-alone document but should be read in conjunction with other relevant guidance such as Good Pharmacoepidemiology Practices of the International Society of Pharmacoepidemiology. Doing business with PHARMO means you have an experienced sparring partner and advisor for communication with authorities on a European level. Click here for examples of studies requested by the EMA.
Please contact us if you need an experienced sparring partner and independent research institute to perform your observational study in response to requests from authorities.