Dorian Regulatory Affairs BV
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Dorian Regulatory Affairs BV Employees in Amsterdam: 2 |
Company profile
The company is located in the Netherlands and was founded early 1999 by Dorine Mulder, who had at that time 16 years experience in regulatory affairs in the pharmaceutical industry, including more than 8 years as Director Regulatory Affairs at the European headquarters of a major biotechnology company. Ms. Mulder has a doktoraal degree (Dutch M.Sc.) in biochemistry and an English M.Sc. degree in toxicology.
During the years in industry, particular expertise has been gained in the fields of biotechnology, oncology, dermatology and gastrointestinal diseases. Products have been registered in the EU through national procedures, the mutual recognition/decentralized procedure as well as the centralised procedure, while national procedures outside Europe have also been concluded successfully. Professional contacts have been established with national authorities as well as regulators at the EMEA.
Science and Technologies or Services
As a small company with extensive practical industry experience, services can be tailored to meet customers' specific needs and time-lines.
Alliances
With a network of consultants throughout Europe, Dorian is able to help with specific local requirements.
Keywords
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Centralised procedure;
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Orphan drugs;
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SME;
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Scientific advice;
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EMEA liaison.