Dorian Regulatory Affairs Company Profile

22:58 EST 13th December 2018 | BioPortfolio

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 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. As a small company with extensive practical industry experience, services can be tailored to meet customers' specific needs and time-lines. And with a network of consultants throughout Europe, Dorian is able to help with specific local requirements.
Dorian Regulatory Affairs can be a partner in optimising the registration package and strategy, and can assist in obtaining (or maintaining) a marketing authorisation at the earliest possible time.


Soestdijkerstraatweg 7


Phone: 31 35 622 19 34
Fax: 31 35 623 06 59

News Articles [411 Associated News Articles listed on BioPortfolio]

Dorian LPG Ltd. Announces First Quarter Fiscal Year 2019 Financial Results

STAMFORD, Conn., Aug. 9, 2018 /PRNewswire/ -- Dorian LPG Ltd. (NYSE: LPG) (the "Company," "Dorian LPG," "we," and "our"), a leading owner and operator of Read more...

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Dorian LPG Ltd. Announces Financing Transactions And Full Repayment Of Bridge Loan Facility

John Hadjipateras, Chairman and Chief Executive Officer of Dorian LPG, commented, "We are pleased to have completed these financing transactions and to have fully Read more...

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PubMed Articles [786 Associated PubMed Articles listed on BioPortfolio]

The Freud-Bleuler Correspondence: French Edition Sigmund Freud, Eugen Bleuler: Lettres, 1904-1937 . Edited by Michael Schröter . Translated by Astor Dorian . Paris : Éditions Gallimard , 2016 , 320 pp., €32.00 .

A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA.

In this study we compared Swissmedic's (SMC's) regulatory marketing authorization decisions to those of the US Food and Drug Administration (FDA) and European drug regulatory authorities (EU). We inve...

Patient Experience Data in US Food and Drug Administration (FDA) Regulatory Decision Making:: A Policy Process Perspective.

The influence of patient advocates on FDA regulatory decision making has increased. Despite enhanced engagement with FDA, there remain challenges to achieving the regulatory goals of patients within F...

Cancer Among Women Treated in the Veterans Affairs Healthcare System.

The Veterans Affairs (VA) healthcare system is a high-volume provider of cancer care. Women are the fastest growing patient population using VA healthcare services. Quantifying the types of cancers di...

Single-use Medical Devices Re-processing: Regulatory Status Quo.

Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the ...

Clinical Trials [546 Associated Clinical Trials listed on BioPortfolio]

Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance

This surveillance is a postmarketing commitment following the marketing authorization for Forxiga(dapagliflozin) in accordance with Standards on Re-examination of New Drugs, notified by th...

The Differential Effects of 3 Different Immunosuppressive

The study is a laboratory investigation comparing the regulatory effects of different immunosuppressive therapies in an in vitro human MLR assay of selecting specific immunosuppressive the...

T-Regulatory Cells in Amyotrophic Lateral Sclerosis

This is an open-label pilot study to determine the safety and tolerability of infusions of autologous CD4+ CD25+ regulatory T cells with concomitant subcutaneous IL-2 injections in 4 subje...

Importance of CD4+CD25+ly in UC1. Investigation of Difference Between Blood Concentration IL 17, IL 33, Regulatory T ly in Patients With UC and Control Group

Mucosal inflammation in patients with UC is the result of immunosuppression disturbance because decreasing number of regulatory T ly and activation IL 17

Assessing the Induction of Long-term Immune Regulation Following Treatment With Lemtrada® (Alemtuzumab).

In this study the investigators wish to test the hypothesis that treatment with Lemtrada is associated with alterations in immune homeostasis in favor of multiple regulatory leukocyte popu...

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More Information about "Dorian Regulatory Affairs" on BioPortfolio

We have published hundreds of Dorian Regulatory Affairs news stories on BioPortfolio along with dozens of Dorian Regulatory Affairs Clinical Trials and PubMed Articles about Dorian Regulatory Affairs for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Dorian Regulatory Affairs Companies in our database. You can also find out about relevant Dorian Regulatory Affairs Drugs and Medications on this site too.

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