General Biotechnology

The Globetrotting Regulator

I am putting in a lot of miles on behalf of international regulatory fraternity.

Like Johnny Cash said, “I’ve been everywhere” — or at least it seems that way. Recently I’ve visited with government health officials in China (both PRC and ROC), the Philippines, Malaysia, Egypt, Algeria, Saudi Arabia, Jordan, the United Arab Emirates, Kuwait, Russia, Brazil, Colombia, South Africa, Indonesia, Kenya, and many other points in-between. And the only thing that’s grown more than my frequent flyer miles is my respect and admiration for those over-worked and under-appreciated civil servants toiling on the front lines of medicines regulation. It’s a global fraternity of dedicated (and generally under-paid) healthcare and health policy professionals devoted to ensuring timely access to innovative medicines and quality generics drugs.  But, just as in similar Western agencies (USFDA, EMA, Health Canada, etc.), “doing the right thing” is often a battle of evolving regulatory science, tight resources, competing priorities … and politics.

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General Biotechnology

Can compliance help marketing and business development?

Journal of Commercial Biotechnology
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Can compliance help marketing and business development?

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ABSTRACT: In many FDA-regulated companies, the marketing and business development departments have a quietly antagonistic relationship with their quality and regulatory affairs colleagues. While compliance is supposed to ensure that a safe, efficacious and high-quality new product reaches the marketplace, marketing and business development executives are left to grumble: how are consumers – much less partners and investors – supposed to learn about and get excited about a new product if their work is so constricted? This paper suggests that there is a way to turn compliance from the millstone around Marketing’s neck to the whetstone that helps hone a sharper competitive edge…

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

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For more information, see the Journal of Commercial Biotechnology website

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