The Anson Group provides successful solutions to clients of all sizes, from small and mid-sized organizations to major corporations and institutions. Providing a range of medical technology commercialization and compliance consulting services to its clients, Anson serves companies throughout the United States, Europe, and Asia.
Commercialization Consulting Services
- Business development
- Product development
- Regulatory research, planning, and issue response
- Regulatory agency liaison
- Overall development planning
- Clinical study design and monitoring
- Formulation development
- Toxicology
- Product approval submissions
- IND, NDA, ANDA, BLA
- INAD, NADA
- IDE, PMA, 510(k), HDE, CE Mark
Compliance Consulting Services
- Quality system design
- Compliance & risk management
- Compliance assessment and remediation
- Auditing
- Quality System Regulation (QSR)
- Good Manufacturing Practices (GMP)
- Good Laboratory Practices (GLP)
- Good Clinical Practices (GCP)
- ISO 9001
- ISO 13485
- Inspection preparedness
- Adverse event response strategies and implementation
- Post marketing support
- Warning letters, product failure investigation
- Phase 4 studies
