REGULATORY AFFAIRS SERVICES IN EUROPE
Dorian Regulatory Affairs B.V. is a small, flexible consultancy company, with extensive experience in development and registration of conventional and biotechnological pharmaceutical products in Europe. For regulatory procedures in the US and Switzerland, collaborations with local consultants have been established.
The company is located in the Netherlands and was founded in 1999 by Dorine Mulder
Dorine Mulder is by training a biochemist (University of Groningen, NL) and a toxicologist (University of Surrey, UK), and has over 25 years of experience with the registration of pharmaceuticals in Europe.
She started her career in 1983 as part of the team establishing the toxicological contract laboratory NOTOX in the Netherlands. Initial experience in regulatory affairs was gained during 16 years in industry, in particular as Director Regulatory Affairs at Chiron in the Netherlands, and Janssen Pharmaceutica in Belgium.
In 1999, Dorine established the consultancy Dorian Regulatory Affairs, specialising in handling European registration procedures for clients not established in Europe or without adequate experience in European regulatory procedures. Over the years, particular experience has been gained in the fields of biotechnology, oncology, dermatology, ophthalmoscopy and gastrointestinal diseases. Products have been registered in the EU through national procedures, the mutual recognition and decentralised procedure as well as the centralised procedure.
Professional contacts have been established with national authorities as well as regulators at the EMA.