Regulatory Affairs Consultants (RAC) Netherlands provides RA services to the pharmaceutical/biotech industry on European Drug Regulatory Procedures.
Our services range from the pre-marketing authorisation application (MAA) phase to the post-MAA phase, including the application for reimbursement (in the Netherlands).
We provide strategic advice on the choice of the procedure, compassionate use programmes, INN applications, ATC applications and are specialized in preparing and submitting Orphan Drug applications and Paediatric Investigational Plans as well as preparing CMC and SmPC variations. For small, start up companies or companies outside the European Union, RAC can also act as the legal representative in (Dutch) regulatory procedures or can provide an interim manager/director.
2011 • kvk 51648180 • e-mail: vandenberg@RA-consultants.nl
Powered by Dutch Web Promotion