Project Description



Pharma Regulatory Connection

210 Niantic River Road
Waterford, CT 06385

Phone: 860-461-5487
Fax: 860-772-2283

Nancy C. Motola, PhD, RAC

General Information
Offering regulatory expertise in discovery, development, registration and commercialization of Drugs and Biologics in a variety of therapeutic areas

Strategic planning & Regulatory submissions, e.g.
• IND, NDA, BLA, 505(b)(2), ANDA, AADA, SNDA, Orphan Drug, SPA
• Regulatory support for Phase 1 – 4 Clinical Trials
• Global regulatory strategies
• Regulatory infrastructure development

FDA meetings, e.g.
• Advisory Committee, Pre-IND, End of Phase 2, Pre-NDA/BLA, Type A-C

CMC & Regulatory Compliance
• Drug & Biologic manufacturing & maintenance
• GMP & Pre-Approval inspection preparation, execution & mitigation
• Recall strategies, execution and support

Product Life-Cycle Development
• New indications & line extension support
• Post-approval manufacturing and maintenance support
• Advertising & promotional material review

Business Development Support
• Regulatory Intelligence
• Regulatory Due Diligence
• Partnership management

Other Information
Ownership: private
CT Employees: 1
World Employees: 1

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