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European drug registration


governmental registration process


European Union's Good Manufacturing Practice


European food label review


European Union Authorized Representative


United Kingdom borderline substance


United Kingdom healthcare expense reimbursement


drug product approval


CE Marking


drug validation


European labeling requirement


European statute


Food and Drug Administration drug registration


European Drug Registration Experts

The following experts are available as European drug registration consultants and European drug registration expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  European Drug Registration - Registration of drugs for market approval, often using EMEA and the EC mutual recognition system.

Synonyms:  EC drug registration

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European Drug Registration Experts
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Expert in Good Clinical Practice (GCP), clinical trials, regulatory authority inspections, audits, QM
Expert is a former GCP inspector with the German Federal Institute for Drugs and Medical Devices [BfArM]. She has led and conducted GCP inspections on behalf of EMA and national authorities all over the world. Expert has experience in assessing the ... See full profile

Brussels, Belgium

Expert in Pharmaceutical Development, strategy planning and execution
Expert graduated in Biology at the University of Utrecht, The Netherlands, in 1984. From 1985-89 he was a PhD student at the University of Basel. The research in the field of gene regulation was carried out at the Friedrich Miescher Institute (FMI; ... See full profile


Expert in Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer's and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic's regulations. See full profile

Quebec, Canada

Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. See full profile

Oklahoma (OK), USA

Expert in Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in ... See full profile

Pennsylvania (PA), USA

Expert in Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare ... See full profile

Illinois (IL), USA

Expert in Market Access and Riembursement of Orphan Drugs in Europe
Expert is a senior executive with expertise in International Market Access and Reibursement in Europe, UK, Canada and Australia. Expert has over 20 years experience in the pharmaceutical sector and played various roles within major Pharma/Biotech ... See full profile



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