Services
I advise startups and growth companies in healthcare, technology, and life sciences. I support clients as a fractional general counsel, providing on-call, informed advice on matters including regulatory compliance, contracts, and business fundamentals.
Regulatory Compliance
Regulatory compliance for healthcare services and products, digital health, clinical trials, and data privacy, such as:
Building a right-sized data privacy program
Delivering digital health services across state lines
Establishing multi-state MSO-PC structures
Developing compliant participant recruitment partnerships for clinical trials
Parsing FDA guidance on classification of products, apps, and devices
Crafting compliant labeling claims
Contracts
Contracts with customers, strategic partners, and vendors, such as:
Negotiating services agreements, clinical trial agreements, and software licensing agreements with life sciences companies, universities, and medical practices
Drafting strategic partnership agreements with large pharma companies, including proof of concept and joint development projects
Advising on contracts and service level agreements with third-party software developers and vendors
Drafting agreements for joint marketing strategies
Drafting agreements for co-development of intellectual property
Business Fundamentals
Business fundamentals, such as:
Employment matters, including employee, consultant, and advisor agreements
Preparation for investor due diligence
Corporate governance