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Regulatory and Clinical Consulting. BioDirect, Inc. is an independent clinical consulting firm whose mission is to assist pharmaceutical companies, particulary biopharmaceutical firms, to bring therapeutics to market by providing a better understanding of FDA and the regulatory process. BioDirect, Inc. provides expertise in the clinical development of biotechnically derived pharmaceuticals. For further information on the services we provide, please see our Services.

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BioDirect, Inc.

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BioDirect, Inc. Home | biodirectinc.com Reviews

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Regulatory and Clinical Consulting. BioDirect, Inc. is an independent clinical consulting firm whose mission is to assist pharmaceutical companies, particulary biopharmaceutical firms, to bring therapeutics to market by providing a better understanding of FDA and the regulatory process. BioDirect, Inc. provides expertise in the clinical development of biotechnically derived pharmaceuticals. For further information on the services we provide, please see our Services.

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BioDirect, Inc. Home | biodirectinc.com Reviews

https://biodirectinc.com

Regulatory and Clinical Consulting. BioDirect, Inc. is an independent clinical consulting firm whose mission is to assist pharmaceutical companies, particulary biopharmaceutical firms, to bring therapeutics to market by providing a better understanding of FDA and the regulatory process. BioDirect, Inc. provides expertise in the clinical development of biotechnically derived pharmaceuticals. For further information on the services we provide, please see our Services.

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biodirectinc.com

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Design of regulatory and clinical strategies for all stages of clinicaldrug development

http://www.biodirectinc.com/services.htm

Design and help implement regulatory and clinical strategies for all stages of clinical drug development. Prepare and review documents for regulatory submission to FDA, e.g., clinical sections of INDs, BLAs, NDAs, Investigator Brochure, Fast Track application. Prepare for Advisory Committee Meetings, e.g., briefing document, practice sessions, slide presentations, Q&A. Participate as a member of data safety committees. Prepare for meetings with FDA: pre-IND, end-of-phase 2, pre-BLA, etc.

2

Reg CV

http://www.biodirectinc.com/regcv.htm

Barbara G. Matthews. MD, MP.H. Regulatory/Clinical Consultant, President. As a consultant to the pharmaceutical industry, I provide guidance on regulatory issues that arise during all stages of drug development and the approval process. Other indications for which I have experience include oncology, neurology, dermatology, angiogenesis, and ophthalmology. The types of products include monoclonal antibodies, proteins, antisense, and cell and gene therapies. Associate Director of Medical Affairs. Division ...

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BioDirect, Inc. Home

Regulatory and Clinical Consulting. BioDirect, Inc. is an independent clinical consulting firm whose mission is to assist pharmaceutical companies, particulary biopharmaceutical firms, to bring therapeutics to market by providing a better understanding of FDA and the regulatory process. BioDirect, Inc. provides expertise in the clinical development of biotechnically derived pharmaceuticals. For further information on the services we provide, please see our Services.

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