Fubin Wu
Co-founder · Safety Engineering
- First-principles safety engineering
- Risk management
- Connected evidence
Leadership & Experts
The people behind strategy, implementation, and execution
GessNet combines company leadership, senior domain expertise, industry consultants, and QMSpace implementation support according to each engagement.
Senior Advisors
Senior Advisors
Susan Neadle
Combination Products Strategy
- Combination products
- Quality systems
- Regulatory strategy
Steven Kaufman
Combination Product Strategy
- Combination products
- Cross-functional alignment
- Product strategy
Douglass Mead
Regulatory & Submission Strategy
- Regulatory strategy
- Regulatory submissions
- Agency interactions
Antony Watson
Regulatory Affairs & Guidance
- Regulatory affairs
- Global markets
- Regulatory guidance
Robin Hwang
Formulation, Delivery Systems & CMC
- Formulation
- Drug-delivery systems
- CMC
Edwin Bills
Risk Management & Standards
- Risk management
- Medical-device standards
- Safety engineering
Shannon Hoste
Human Factors Strategy
- Human factors
- Usability engineering
- Use-related risk
Frank Li
Pharmaceutical Clinical & Regulatory Strategy
- Clinical development
- Regulatory strategy
- Pharmaceutical development
Industry Consultants
Industry Consultants
Mercedes Massana
Risk Management & Product Development Consultant
- Risk management
- Safety engineering
- Combination products
Jian Cao
Program & Portfolio Management Consultant
- Program management
- Portfolio management
- Development planning
Scott Brown
Medical-Product Consultant
- Product development
- Regulatory execution
- Quality systems
Jessica Eisner
Medical-Product Consultant
- Product development
- Quality systems
- Deliverable execution
Matt Lamore
Medical-Product Consultant
- Product development
- Quality
- Regulatory execution
Justin Shimidt
Medical-Product Consultant
- Product development
- Digital implementation
- Regulated medical products
Richard Wu
Medical-Product Consultant
- Consulting execution
- Product development
- Implementation
Helene Wu, Ph.D.
Senior Quality & Medical Device Consultant
- Design controls
- Risk management
- Combination products
QMSpace Implementation & Support
QMSpace Implementation & Support
Chris Chia
QMSpace Support & Implementation Specialist
- QMSpace configuration
- Onboarding
- Implementation
Randy Kipnis
QMSpace Support & Implementation Specialist
- QMSpace implementation
- Configuration
- User enablement
Bhavin Mistry
IT Support Specialist
- IT systems
- Infrastructure
- Technical support
Connor Schmidt
QMSpace QA & Implementation Specialist
- Quality assurance
- Software testing
- Release readiness
Justin Wu
Data Scientist – Digital Solutions
- Data analytics
- AI-enabled workflows
- QMSpace data models
How the team works
Clear responsibility from direction through delivery
The engagement structure is designed so strategic advice, product-specific execution, platform implementation, review, and client decisions remain clearly assigned.
Leadership and senior experts
Set direction, address complex decisions, and provide specialized regulatory, quality, technical, and risk judgment.
Industry consultants
Turn direction into assessments, plans, analyses, documentation, coordination, and hands-on product work.
Implementation and support
Configure QMSpace, structure and migrate information, train users, test releases, and sustain adoption.
Bring the right expertise to the problem
Describe the product, development stage, and technical or organizational challenge. GessNet will identify the relevant starting team.