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The Gnomon Group, Pharmaceutical and Biotechnology Development Consulting Group

A pharmaceutical and biotechnology development consulting group providing regulatory, clinical, preclinical, CMC, medical writing, and project management services for drug development companies.

http://www.thegnomongroup.com/

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The Gnomon Group, Pharmaceutical and Biotechnology Development Consulting Group | thegnomongroup.com Reviews
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A pharmaceutical and biotechnology development consulting group providing regulatory, clinical, preclinical, CMC, medical writing, and project management services for drug development companies.
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The Gnomon Group, Pharmaceutical and Biotechnology Development Consulting Group | thegnomongroup.com Reviews

https://thegnomongroup.com

A pharmaceutical and biotechnology development consulting group providing regulatory, clinical, preclinical, CMC, medical writing, and project management services for drug development companies.

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thegnomongroup.com thegnomongroup.com
1

The Gnomon Group Case Studies, advancing the development programs of its clients.

http://www.thegnomongroup.com/case_studies.html

The Gnomon Group has provided a wide variety of services to the pharma industry. Click on the Case Studies below to see how The Gnomon Group has been able to advance the development programs of our clients. Contact us today to see how we can help you. US Agent Representation for European Pharma Company Pre-IND Interactions, IND Submission, Regulatory Support. Regulatory Affairs/Drug Development Support to a Virtual Company for a 505(b)2 Combination Product. Small Pharma Regulatory Affairs Support.

2

The Gnomon Group Bios of Mike Dalton, Pharm.D. and Tom Shumaker, M.S.

http://www.thegnomongroup.com/bios.html

In addition to the founding partners below, The Gnomon Group maintains a network of highly experienced associates in related fields, such as statistics/data management, medical writing, clinical pharmacology, and toxicology. A description of capabilities document for our associates is available for your review. Mike Dalton, Pharm.D. Tom Shumaker, M.S.

3

About The Gnomon Group, providing a full range of development expertis to large and small pharma companies.

http://www.thegnomongroup.com/About_Us.html

Mike Dalton and Tom Shumaker founded The Gnomon Group in 2007. Mike and Tom have over 50 years of combined work experience in a variety of large and small pharma companies and CROs. Seeing the challenges faced by startup, small and mid-sized pharma companies in accessing the pharmaceutical development experience needed to move promising ideas forward, they formed The Gnomon Group to provide virtual project teams to these companies.

4

The Gnomon Group Services, supporting the needs of the pharmaceutical and biotech industry.

http://www.thegnomongroup.com/services.html

The Gnomon Group provides a variety of services to support the needs of the pharmaceutical and biotech industry, including:. Regulatory Strategy Development (All Phases). Regulatory Authority (FDA) and Foreign Company Liaison. Regulatory Authority (FDA) meetings including pre-IND, end of Phase 2, clinical development meetings, pre-NDA, FDA Advisory Committee meetings, international meetings. Regulatory Submissions (Electronic and Paper). Initial IND and amendments. Contact with All FDA Review Divisions.

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