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Heyer Regulatory Solutions is the expert source for innovative global regulatory strategies. We help get your medical device to market and keep it there.

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Heyer Regulatory Solutions is the expert source for innovative global regulatory strategies. We help get your medical device to market and keep it there.
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regulatory affairs, HEYER REGULATORY SOLUTIONS, LLC Home | heyer-regulatory.com Reviews

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Heyer Regulatory Solutions is the expert source for innovative global regulatory strategies. We help get your medical device to market and keep it there.

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regulatory affairs, HEYER REGULATORY SOLUTIONS, LLC News and Events

http://www.heyer-regulatory.com/newsandevents.html

The expert source for global regulatory strategies. Learn "How to Enhance Your Medical Device Approval Process" - Sheila Hemeon-Heyer interview with Scott Nelson of Medsider.com. Meeting the Challenges of Today's Changing Regulatory Environment. CINDE Life Sciences Forum, San Jose, Costa Rica, March 19, 2013. Hot Topics in FDA Regulatory Affairs. FDLI Medical Device Regulatory, Compliance and Litigation Conference, Washington, DC, March 4, 2013. Changes in FDA's 510(k). Hot Topics in Advertising and Prom...

2

regulatory affairs, HEYER REGULATORY SOLUTIONS, LLC About

http://www.heyer-regulatory.com/about.html

Heyer Regulatory Solutions LLC. The expert source for global regulatory strategies. Sheila Hemeon-Heyer, JD, RAC. Sheila Hemeon-Heyer formed Heyer Regulatory Solutions in 2010 in order to provide medical device, combination product, and in vitro diagnostic companies with an experienced choice for their global regulatory needs. Heyer Regulatory Solutions brings to you the experience of:. Working within FDA - knowing what information FDA reviewers need to make their decisions. Powered by Network Solutions.

3

regulatory affairs, HEYER REGULATORY SOLUTIONS, LLC Home

http://www.heyer-regulatory.com/home.html

The expert source for global regulatory strategies. Heyer Regulatory Solutions is the expert source for innovative strategies to get your medical device, combination product, or diagnostic to market and keep it there. Whether you are a start up company new to the world of medical device regulation or an established company looking to outsource, Heyer Regulatory Solutions has the experience, knowledge, skills, and contacts to help you meet your global business goals. Powered by Network Solutions.

4

regulatory affairs, HEYER REGULATORY SOLUTIONS, LLC Services

http://www.heyer-regulatory.com/services.html

Heyer Regulatory Solutions LLC. The expert source for global regulatory strategies. Heyer Regulatory Solutions provides a comprehensive array of services to help you meet the global regulatory requirements for your products and achieve your worldwide marketing goals. Building on 26 years of experience, we work closely with you to meet your needs for success. Our US and international services include, but are not limited to:. Clinical Study Design, Documentation and Project Management. Regulatory agencies...

5

regulatory affairs, HEYER REGULATORY SOLUTIONS, LLC Client Testimonials

http://www.heyer-regulatory.com/clienttestimonials.html

Heyer Regulatory Solutions LLC. The expert source for global regulatory strategies. What They Are Saying. Gail Tisack, Chief Legal Counsel. Jean Marie Vogel, Chief Executive Officer. Jim Wilkie, Chief Operating Officer. And without reservation.". Jeff Hersh, MD, PhD, Chief Medical Officer. Jon McGrath, CEO. 8220;Sheila is a scholar in FDA medical device regulations and their interpretations. This knowledge, coupled with her having worked for the FDA and industry, makes her uniquely qualified to assis...

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regulatory affairs, HEYER REGULATORY SOLUTIONS, LLC Home

The expert source for global regulatory strategies. Heyer Regulatory Solutions is the expert source for innovative strategies to get your medical device, combination product, or diagnostic to market and keep it there. Whether you are a start up company new to the world of medical device regulation or an established company looking to outsource, Heyer Regulatory Solutions has the experience, knowledge, skills, and contacts to help you meet your global business goals. Powered by Network Solutions.

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