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ArbitConsultingLLC

Regulatory Strategy and support. For industry, academia, and investigator-initiated clinical research. We have submitted dozens of successful IND, IDE, 510k, PMA, NDA and BLA applications in a variety of therapeutic areas including orphan drugs, expanded access drugs, oncology, pediatrics, cosmetic, as well as dietary and nutritional supplements.

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Alexander Arbit

2418 ●●●●●d Trl

Min●●●nka , MN, 55305

US

1.61●●●●8788
aa●●●●@gmail.com

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Regulatory Strategy and support. For industry, academia, and investigator-initiated clinical research. We have submitted dozens of successful IND, IDE, 510k, PMA, NDA and BLA applications in a variety of therapeutic areas including orphan drugs, expanded access drugs, oncology, pediatrics, cosmetic, as well as dietary and nutritional supplements.
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ArbitConsultingLLC | arbitconsulting.com Reviews

https://arbitconsulting.com

Regulatory Strategy and support. For industry, academia, and investigator-initiated clinical research. We have submitted dozens of successful IND, IDE, 510k, PMA, NDA and BLA applications in a variety of therapeutic areas including orphan drugs, expanded access drugs, oncology, pediatrics, cosmetic, as well as dietary and nutritional supplements.

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arbitconsulting.com arbitconsulting.com
1

About Us - ArbitConsultingLLC

http://www.arbitconsulting.com/aboutus

Arbit Consulting LLC provides FDA regulatory strategy and support for industry, academia, and investigator-initiated clinical research. In an increasingly competitive and complex environment researchers and business executives need to think and work in ways that accelerate their projects through milestones to successful completions. Arbit Consulting and its affiliates, with decades of experience in many areas of pertinent expertise, can help you do that.

2

Services - ArbitConsultingLLC

http://www.arbitconsulting.com/services

Arbit Consulting and its affiliates can provide various levels of guidance, support, and assistance in the following ways. Review and explanation of IND and IDE regulations. Provide education and training for sponsors, investigators, and sponsor-investigators regarding their regulatory obligations. Determine predicate devices and product classification. Assess the applicability of an IND or IDE to enable the lawful conduct of clinical trials. Assist with and submit IND and IDE applications to FDA. Assist...

3

ArbitConsultingLLC

http://www.arbitconsulting.com/home

Regulatory Strategy and support for industry, academia, and investigator-initiated clinical research.

4

News item 1 - ArbitConsultingLLC

http://www.arbitconsulting.com/news/newsitem1

Posted Apr 15, 2012, 5:24 AM.

5

News - ArbitConsultingLLC

http://www.arbitconsulting.com/news

Posted Apr 15, 2012, 5:24 AM. Posted Apr 15, 2012, 5:24 AM.

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Regulatory Strategy and support. For industry, academia, and investigator-initiated clinical research. We have submitted dozens of successful IND, IDE, 510k, PMA, NDA and BLA applications in a variety of therapeutic areas including orphan drugs, expanded access drugs, oncology, pediatrics, cosmetic, as well as dietary and nutritional supplements.

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