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Schiff & Company, Inc.

1129 Bloomfield Ave.
West Caldwell, NJ 07006
Tel: 973/227-1830
Fax: 973/227-5330

E-mail: schiffandcompany@aol.com

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Description:
Provides compliance, regulatory affairs, and clinical research services worldwide. The company conducts GMP, GCP, and GLP audits, and monitors clinical studies for drugs, biologics, diagnostics, and devices. It represents both domestic and international organizations before FDA and foreign regulatory bodies. The company plans regulatory strategy, prepares clinical development plans, performs qualifications and validations, writes standard operating procedures, and conducts due diligence. The firm prepares INDs, NDAs, BLAS, IDEs, PMAs, 510(k)s, and DMFs.

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