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Schiff & Co. 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:
Conducts and monitors clinical studies for drugs, biologics, diagnostics, and devices. The company conducts international regulatory affairs, compliance, and clinical research. It represents both domestic and international organizations before FDA and foreign regulatory bodies. Company staff plan regulatory strategy; prepare clinical development plans; perform GMP, GCP, GLP, and validation audits; write standard operating procedures; and conduct due diligence. The firm prepares INDs, NDAs, BLAs, IDEs, PMAs, 510(k)s, and DMFs in electronic and paper formats.
Categories this company is listed under in the In Vitro Diagnostics Suppliers Directory:
- Consulting Services: Legal Affairs (14 companies)
- Consulting Services: Process Development and Validation (63 companies)
- Consulting Services: Product R&D, Design (76 companies)
- Consulting Services: Product Testing (68 companies)
- Consulting Services: Quality Systems Certification (54 companies)
- Consulting Services: Regulatory Affairs (77 companies)
- Consulting Services: Site Selection, Facility Design (10 companies)
- Consulting Services: Software Design, Programming (33 companies)
