INTRODUCTION
Founded in February 2004, RegAdviZe (regulatory advice from A to Z in drug development),
is an independent consultancy company providing regulatory services to biotech and pharmaceutical companies, academia and other institutions working in the health care business.
With more than 30 years in the pharmaceutical industry, RegAdviZe management possesses extensive knowledge and experience in R&D. Main focus is on strategic management of Regulatory Affairs in the development process, submission and product approval as well as product life cycle activities. RegAdviZe offers to assist client’s in-house resources by making experienced consultancy available.
Drug development is a long and complicated process. It is extremely time and resource consuming. Development of New Chemical Entities takes 8-12 years and costs 400 - 800 million Euros, while line extensions and generics require 5-7 years and cost 400.000 - 10 million Euros. In addition, legislation and guidelines heavily control the pharmaceutical industry.
While various specialist functions deal with specific development requirements, the overall guidance and liaison with the health authorities is the responsibility of Regulatory Affairs (RA). These activities therefore influence most if not all functional areas in drug development.
Knowledge and a common understanding of the regulatory environment (the pharmaceutical legal framework, application procedures, terminology, etc.) are a prerequisite for a successful development of a medicinal product.
Efficient strategic management of regulatory affairs in the development process is thus of critical importance to ensure the best label, competitive positioning and commercial return, and also reduce time to market and overall development costs.
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 | The managing director in front
of the RegAdviZe office.
(Located at Scion DTU - see Domicile) |
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