Startups
What Do We Assist With?
At Genesis, we provide comprehensive regulatory advisory support across healthcare and life sciences transactions. Our due diligence process is designed to rigorously evaluate technical, financial, and operational factors, ensuring that startups are equipped with the insights needed to make informed decisions and mitigate risk.
IP Portfolio Strategy
- Trademarks and Patents
- IP Portfolio Creation
- IP Licensing & Assignments
- IP Due Diligence
- Technology Transfers
Regulatory & Legal
- Regulatory Strategy Pathway
- Commercial Agreements
- Documentation for post transaction integration issues.
- Market Entry Regulatory Guidance and Implementation
Commercial Strategy
- Transaction Advisory
- Licensing and Tech Transfers
- Competitive & Scientific Landscape Analysis
- Target Product Profile (TPP) Design
Brand Strategy & Naming
- Go-To-Market Strategy
- Pricing & Channel Strategy
- Launch Planning & Commercial Playbooks
Empowering Future Innovations
How Do We Add Value?
We develop tailored strategies for each client, informed by decades of experience across biopharma, digital health, health technology, tools and diagnostics, healthcare services, and medical technology. With expertise spanning all key subsectors of healthcare, our team brings deep knowledge and insight to every transaction.
Our Advisory
Our team possesses deep expertise in conducting due diligence for life sciences and healthcare product and service transactions, including financings, licensing agreements, and mergers and acquisitions. We bring extensive experience in assessing potential risks across the entire product lifecycle—from development through commercialization—covering clinical development, manufacturing, partnerships, and promotional activities.
US FDA, EU GMP, ANVISA, WHO GMP, NAFDAC, DCGI, product approvals, clinical trials, pricing, and liability issues.
Compliance training, and regulatory updates.
Advisory on digital health, diagnostics, health applications, and data-driven innovations.
Compliance frameworks, risk management, and policy alignment with evolving regulations.
Drafting and updating policies on ethics, compliance, data protection, and privacy.
Advisory on robotic surgery, MedTech innovations, Software as a Medical Device, AI Powered Medical Device and new healthcare technologies.
Structuring and advisory for new models in healthcare and life sciences, including revenue share models, logistics, and licensing solutions.
Guidance on UCPMP Code, Drugs and Magic Remedies Act, and ASCI advertising standards.
Advisory and documentation for compliance across all stages of clinical research.
Healthcare Transaction Advisory
We advise companies in the life sciences and healthcare sectors across every stage of their business lifecycle, delivering comprehensive legal and strategic guidance. With a deep understanding of the economic, market, regulatory, enforcement, and political environments in which healthcare companies operate, our global team provides integrated solutions tailored to both legal and business needs.
Our Expertise
- Corporate Structure & Governance – Advising on entity formation, governance frameworks, and operating documentation.
- Mergers & Acquisitions – Structuring, negotiating, and executing strategic acquisitions and dispositions.
- Intellectual Property – Providing guidance on initial IP protection strategies and licensing arrangements.
- Financing – Supporting growth through early-stage equity and debt financing solutions.
- Licensing & Distribution – Structuring partnerships to enhance market access and commercial reach.
- Capital Markets – Advising on IPOs and capital-raising activities in the public markets.
- Go-Private Transactions – Assisting with dispositions, restructuring, and private ownership transitions.
Diversified Advising Experience
A global medical device company – on its diabetes business across 10 jurisdictions, evaluating the regulatory and commercial feasibility of marketing, selling, and shipping products directly to customers in each market.
Medical Technology
Multi-National
A European medical technology company – on all aspects of medical device regulation, including:
(i) developing a wearable device strategy from regulatory planning through product design, and
(ii) supporting international marketing campaigns to ensure compliance and market readiness.
Medical Technology
Europe
A Latvian global distribution company – on product portfolio curation and leading licensing negotiations with marketing authorization holders across the EU, MENA, and UK markets to expand their reach.
Distribution
Latvia
An Indian healthcare startup – on early-stage product development and preparation of regulatory documentation to position the company for future commercialization and investment.
