Our experience in consulting in regulatory affairs began in 1988, with a company of a different name.
Our goal is to build a plan of regulatory activities that meets the Client’s needs and responds to regulatory requirements, with the support of an international team of Experts (Regulatory Intelligence network).
The Services we offer to our Clients are:
– Consulting in the development process
– Interaction with European Regulatory Agencies.
– Assistance in requesting Scientific Advice from Regulatory Agencies.
– Assistance in Orphan Drug Designation
– Planning and support in the registration process, for national and European procedures
– Product maintenance: updates, changes, and renewals