Dorian Regulatory Affairs 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 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.
Location
Soestdijkerstraatweg 7
Hilversum
NL-1213
Netherlands
Contact
Phone: 31 35 622 19 34
Fax: 31 35 623 06 59
Email: info@dorian.nl
News Articles
Wanted: Experienced Regulatory Affairs Personnel
Our recent research suggests intensifying competition among pharmaceutical companies for capable regulatory affairs employees. In fact, experienced regulatory affairs personnel can be counted as a whi...
Regulatory and Compliance Functions Within Medical Affairs Teams
Over the past several years, we have seen a slow shift among regulatory affairs and compliance groups in the pharmaceutical industry as these groups move under medical affairs oversight. This hasn’t...
Cutting Edge Information Finds Regulatory Affairs Difficult Both at Home and Abroad
Half of all drug companies surveyed by Cutting Edge Information said that their regulatory affairs team interacts with correspondents in the FDA once a week or more....
Top 50 Pharma Companies Increase Regulatory Affairs Budgets by 27%
PA new study finds that top 50 pharmaceutical companies have increased their regulatory affairs budgets by an average 27% since 2010. Small drug manufacturers, as well as medical...
Percentage of Pharmaceutical Companies Outsourcing Regulatory Affairs Budgets Increases to 68%
A majority of surveyed pharmaceutical companies outsource at least part of their regulatory affairs budget. This is up 5% from 2010, demonstrating that fewer drug companies...
VANCOUVER, Feb. 4, 2013 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced the selection of Quintiles to provide comprehensive post-marketing lifecycle safety and global regulator...
Dorian Gray gene could add decades to life
American researchers found that the gene, which has previously been implicated in Parkinson’s Disease, extended the healthy lifespan of fruit flies by more than 25 per cent. (The Telegraph)
Pharmaceutical Regulatory Affairs Teams Buck Trend of Budget Cuts
A new study finds that despite budget cuts in pharmaceutical companies as a result of the “Great Recession,” regulatory affairs teams have experienced a consistent increase in...
Drugs and Medications
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PubMed Articles
Evaluation of platelet transfusion clinical trials.
News from the Biological Stain Commission No. 10.
Abstract In the 10th issue of News from the Biological Stain Commission (BSC), under the heading of Regulatory affairs, the Biological Stain Commission's International Affairs Committee presents infor...
Response to Protocol Review Scenario: One size does not fit all.
Sample characterization: A priori to evaluating absorption, distribution, and metabolism.
Future good scientific publishing practice will necessitate wider data transparency.
Clinical Trials
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...
Mucosal inflammation in patients with UC is the result of immunosuppression disturbance because decreasing number of regulatory T ly and activation IL 17
Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy
Along structural IgA abnormalities, hyperproduction of IgA is thought to play a role in the pathogenesis of primary IgA nephropathy. CD4+CD25+Fox3P regulatory T cells are instrumental in s...
Rapamycin and Regulatory T Cells in Kidney Transplantation
The immune system response is mediated by the interaction between the antigen presenting cell (APC), CD4+ T helper cells (Th) and CD4+ CD25+ regulatory T cells, a subgroup of CD4+ T cell w...
Angeliq Regulatory Post Marketing Surveillance
Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy in real practice for the indication approved by Korea Food and Drug Administration (KFDA). Thi...
Companies
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