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Schiff & Company, founded in 1982, is an international Regulatory Affairs and Clinical Research Organization. Senior Management personnel each have more than 25 years experience in the health care and FDA regulatory fields. Schiff & Company conducts and monitors clinical studies for drugs, biologics, diagnostics, and devices. We represent both domestic and international organizations to the FDA and to foreign regulatory bodies. We write all appropriate regulatory filings. Our staff plans regulatory strategy, prepares clinical development plans, performs GMP and validation audits, writes SOPs and conducts due diligence. Our expertise in product development includes but is not limited to rheumatology, cardiology, anti-infectives, oncology, ophthalmology, and dermatology. The Food and Cosmetics Division handles GMP compliance, import/export issues, food additives and color petitions, nutrition labeling and food and ingredient R&D.
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Phone: (973) 227-1830 Fax: (973) 227-5330