Regulatory Strategy & Advisory

• US regulatory strategy development

• US submission review and FDA interaction strategy

• Regulatory gap assessments and risk mitigation

• Timeline planning and pathway guidance

• Venture capital support: guidance on regulatory readiness to aid fundraising

• OUS regulatory strategy planning (Canada, EU, China, Japan, Australia/NZ)

• M&A regulatory due diligence

US Regulatory Submissions

• 510(k) Premarket Notifications

• De Novo Applications

• Q-Submissions (Pre-Submissions, Submission Issue Requests, Study Risk Determinations, Informational Meetings)

• Premarket Approvals (PMAs)

• Investigational Device Exemptions (IDEs)

• Breakthrough Device Designation applications

• Safer Technologies Program (STeP) applications

• Small Business Qualification (SBQ) certification

Documentation Support

• Device registration and listing support

• U.S. Agent services for foreign establishments

• Regulatory support for QMS and design control documents

Marketing & Labeling Compliance

• Claims review and advertising/promotion compliance

• Instructions for Use (IFU) development

• Labeling (Labels, IFU, User Manual) review

Training & Education

• Customized regulatory training for internal teams, startups, and executive leadership

• Guidance on regulatory best practices for early-stage product development