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Access BIO - specializes in assisting in the development of drug, biologic and medical device products.

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Access BIO - specializes in assisting in the development of drug, biologic and medical device products.
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2 human subjects protection
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Access BIO - Home Page. | accessbio.com Reviews

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Access BIO - specializes in assisting in the development of drug, biologic and medical device products.

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Access BIO - About Us.

http://www.accessbio.com/about.htm

Download Full Joy Cavagnaro Resume. Download Full Richard Lewis Resume. Joy A Cavagnaro, PhD, DABT, RAC. Richard M. Lewis, Ph.D.

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Access BIO - specializes in assisting in the development of drug, biologic and medical device products.

http://www.accessbio.com/links.htm

Preclinical pharmacology/toxicology programs to support Phase I clinical trials. Regulatory strategies to gain competitive advantage. Rapid and uninterrupted clinical development. Strategies for combination products. Meeting with the FDA. What's new at the Center for Biologics Evaluation and Research (CBER). Guidance for Industry: S6, Preclinical Safety Evaluation of. Guidance for Industry M3, Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals.

3

Access BIO - Services Available.

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Preclinical pharmacology/toxicology programs to support Phase I clinical trials. Regulatory strategies to gain competitive advantage. Rapid and uninterrupted clinical development. Strategies for combination products. Meeting with the FDA. Compliance with FDA, ICH and ISO guidances. GLP, GMP evaluation. Compliance with FDA Guidance. Preparation of regulatory documents and applications. Development of Informed Consent Documents. Pre-IND, IND, BLA, NDA.

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Access BIO - Home Page.

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Preclinical pharmacology/toxicology programs to support Phase I clinical trials. Regulatory strategies to gain competitive advantage. Rapid and uninterrupted clinical development. Strategies for combination products. Meeting with the FDA. Access BIO is a consulting group which specializes in assisting in the development of drug, biologic and medical device products. Let us help you in developing the best approach and well-defined protocols in the clinical and animal studies to speed FDA product approval.

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Preclinical pharmacology/toxicology programs to support Phase I clinical trials. Regulatory strategies to gain competitive advantage. Rapid and uninterrupted clinical development. Strategies for combination products. Meeting with the FDA. Access BIO is a consulting group which specializes in assisting in the development of drug, biologic and medical device products. Let us help you in developing the best approach and well-defined protocols in the clinical and animal studies to speed FDA product approval.

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Access BIO - Home Page.

Preclinical pharmacology/toxicology programs to support Phase I clinical trials. Regulatory strategies to gain competitive advantage. Rapid and uninterrupted clinical development. Strategies for combination products. Meeting with the FDA. Access BIO is a consulting group which specializes in assisting in the development of drug, biologic and medical device products. Let us help you in developing the best approach and well-defined protocols in the clinical and animal studies to speed FDA product approval.

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Preclinical pharmacology/toxicology programs to support Phase I clinical trials. Regulatory strategies to gain competitive advantage. Rapid and uninterrupted clinical development. Strategies for combination products. Meeting with the FDA. Access BIO is a consulting group which specializes in assisting in the development of drug, biologic and medical device products. Let us help you in developing the best approach and well-defined protocols in the clinical and animal studies to speed FDA product approval.

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