The Gnomon Group, LLC
Regulatory Affairs Consulting
Services
The Gnomon Group provides a variety of services to support the needs of the pharmaceutical and biotech industry, including:
The Gnomon Group provides a variety of services to support the needs of the pharmaceutical and biotech industry, including:
Regulatory Strategy Development
(All Phases)
Regulatory Authority (FDA) and Foreign Company Liaison
(All Phases)
Regulatory Authority (FDA) and Foreign Company Liaison
- Regulatory authority (FDA) meetings including pre-IND, end of Phase 2, clinical development meetings, pre-NDA, FDA Advisory Committee meetings, international meetings
Regulatory Submissions (Electronic and Paper)
- Initial IND and amendments
- Original NDA, amendments, and supplements
- International submissions (coordinated with local companies)
- Electronic submissions (IND and Marketing applications, in conjunction with electronic submission vendor)
Preparation of Regulatory Reports and Documents
- Regulatory authority (FDA) meeting request and briefing documents
- IND documents
- Annual reports
- Alert safety reports
- Orphan Drug applications
- Investigator's brochures
- NDA documents
- PSUR and other NDA post-marketing reports
Review of Advertising and Promotional Material
Setup and Maintenance of Electronic and Paper IND Regulatory Files
Project Management
Drug Safety Consulting
CMC Development Strategy, including Vendor Inspection and Evaluation
Contact with All FDA Review Divisions
Please contact Tom or Mike for a confidential review of your regulatory needs.
