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Advyzom is a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for our partners in the pharmaceutical and healthcare industry. Post a Comment Cancel reply. You must be logged in. To post a comment. Arch Bipartners Selects D3 Medicine and Advyzom to develop Human Clinical Trial and Regulatory Strategy for Brain Tumor Targeting Technology. My 29, 2014. New Jersey / Washington DC.

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Advyzom | Strategic Regulatory and Consulting Services | advyzom.com Reviews

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Advyzom is a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for our partners in the pharmaceutical and healthcare industry. Post a Comment Cancel reply. You must be logged in. To post a comment. Arch Bipartners Selects D3 Medicine and Advyzom to develop Human Clinical Trial and Regulatory Strategy for Brain Tumor Targeting Technology. My 29, 2014. New Jersey / Washington DC.

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Advyzom | Strategic Regulatory and Consulting Services | advyzom.com Reviews

https://advyzom.com

Advyzom is a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for our partners in the pharmaceutical and healthcare industry. Post a Comment Cancel reply. You must be logged in. To post a comment. Arch Bipartners Selects D3 Medicine and Advyzom to develop Human Clinical Trial and Regulatory Strategy for Brain Tumor Targeting Technology. My 29, 2014. New Jersey / Washington DC.

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Advyzom | People

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Cynthia Dinella, R.Ph. Pharm.D. Lisa Maffei Luther, MS. Jackie Sterner, PhD. Global Head of Medical Writing and Publications. Angela Windt, Pharm.D., R.Ph. Senior Director, Regulatory Strategy. Joanna Waugh, BSc (Hons). Executive Director, Regulatory Strategy. Karen H. Noh, R.Ph., Pharm.D. Director, Regulatory Strategy. Rula Ibrahim-Saker, R.Ph. Pharm.D. Director, Regulatory Strategy. Regulatory Operations and Submissions Manager. Post a Comment Cancel reply. You must be logged in. To post a comment.

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Advyzom | News

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December 18, 2012. FDA Draft Guidance: Providing Summary Level Clinical Site Data for CDER’s Inspection Planning. December 14, 2012. FDA Draft Guidance: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products. September 10, 2012. Dr Cynthia Dinella Selected to Facilitate MIT’s Global Regulatory Innovation and Adaptive Licensing Program Session. July 24, 2012. July 15, 2012. Angela Windt, Pharm.D., R.Ph joins Advyzom. June 12, 2012. The guidance discusses the r...

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Advyzom | Services

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Fast Track/Orphan Drug Designations. Qualified Infectious Disease Product Designations. Global Regulatory Strategic Plans. Risk Management and REMS. Advertising and Promotion input and review. RTFs, Complete Response Letters, Safety Issues. Clinical protocol input and review. Adaptive design trials input. NDA filing team leadership. Strategic Medical Writing and Publications. IND Summaries/General Investigational Plan. Clinical Study Protocols/Study Reports. NDA/BLA/MAA Clinical and Pre-Clinical Summaries.

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Advyzom | About Advyzom

http://www.advyzom.com/about-advyzom

Advyzom is a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for our partners in the pharmaceutical and healthcare industry. We are recognized insightful leaders who seek and create opportunities throughout the product lifecycle to ensure each client’s asset is successfully transformed into a valuable therapy for patients. Our experienced team has successfully navigated across therapeutic areas, interacting with FDA Divisions a...

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Advyzom | Commitment

http://www.advyzom.com/commitment

Needs are our priority and our reputation. We passionately develop your products, your people and your programs. We connect the dots with you, for you and if need be, refer you. We seek and implement innovative solutions to advance your strategic goals. Post a Comment Cancel reply. You must be logged in. To post a comment. Berkeley Heights, NJ 07922.

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Advyzom | Strategic Regulatory and Consulting Services

Advyzom is a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for our partners in the pharmaceutical and healthcare industry. Post a Comment Cancel reply. You must be logged in. To post a comment. Arch Bipartners Selects D3 Medicine and Advyzom to develop Human Clinical Trial and Regulatory Strategy for Brain Tumor Targeting Technology. My 29, 2014. New Jersey / Washington DC.

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