Life Sciences & Healthcare Law

Sulin Shah

Law Offices of Sulin Shah

Practical, business-oriented legal counsel for life sciences companies across pharma, biotech, and medical device, with particular depth in product launches and commercialization.

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About

A Trusted Partner
Across the Product Lifecycle

Sulin Shah is a seasoned legal and compliance executive with deep expertise in life sciences companies, including pharma, biotech, and medical device. He works with organizations of all sizes, from early-stage and clinical-stage companies to publicly traded enterprises, providing the right level of legal support for each client's needs, whether that means day-to-day operational counsel, project-based work, or serving as an embedded fractional General Counsel.

He has advised companies across the full product lifecycle, from clinical-stage drug development and government-funded programs to post-approval commercialization. He has particular depth in product launches and commercialization, having counseled companies through multiple launches across therapeutic areas including Prader-Willi syndrome, Niemann-Pick Type C, polycythemia vera, and hemophilia.

Previously, Sulin served as VP, U.S. General Counsel at Orphazyme and PharmaEssentia, and spent over a decade at Baxter International and its successor entities (Baxalta, Shire, and Takeda), where he held progressively senior roles overseeing legal matters for the company's market-leading hemophilia franchise. He began his legal career at McDermott Will & Emery, one of the country's leading healthcare law firms, where he built a strong transactional foundation in health law and M&A.

Sulin earned his B.S. in Business Administration from the University of Illinois at Urbana-Champaign and his J.D. from Northwestern University School of Law.

Sulin Shah

Education

Northwestern University School of Law, J.D.

Education

University of Illinois, Urbana-Champaign
B.S. Business Administration

Industries

Biotechnology · Pharmaceutical · Rare Disease · Life Sciences · Veterinary

Based In

Chicago, Illinois

Services

Practice Areas

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Fractional General Counsel

Serving as embedded interim or ongoing General Counsel for life sciences companies at any stage, from startups that need their first lawyer to established organizations managing a transition. Includes managing and coordinating specialist outside counsel to extend capacity efficiently. Senior legal leadership scaled to fit your needs and budget.

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Compliance & Regulatory

Building compliance programs from the ground up, including policies, promotional review (PRC/MRC), Sunshine Act reporting, HCP engagement, privacy compliance, and FDA regulatory strategy.

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Commercialization & Launch

End-to-end launch readiness legal support, including market access, specialty pharmacy, GPO, and hospital customer contracting to supply chain, communications, and commercial structuring.

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Transactions & Contracting

Negotiating and structuring M&A transactions, licensing agreements, capital markets matters, and commercial agreements of all kinds, including oversight of intellectual property portfolio strategy.

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Corporate Governance

Advising boards and executive leadership on governance matters, including board management, subsidiary governance, and supporting public company obligations such as periodic filings and exchange compliance.

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Employment Matters

Advising on employment matters across the organization, including compensation design, non-compete agreements, human resources structuring, and employment issues arising from acquisitions and integrations.

Why Fractional

Seasoned Life Sciences Expertise,
Right-Sized for You

Life sciences companies across pharma, biotech, and medical device face some of the most demanding legal environments in any industry. Regulatory approvals, specialty contracting, compliance programs, capital raises, M&A, employment issues, and a board that needs counsel. All of it, often at once, and often before the company is large enough to justify a full-time GC.

That is the gap a fractional GC fills. Someone who has sat in the GC chair at life sciences companies, knows what a product launch actually requires, and can step in and handle the full range of what your business needs. Senior, industry-specific legal leadership that fits your budget and your stage, and scales with you as you grow.

Industry-specific, from day one

No learning curve on FDA, compliance, or how a drug launch works.

Embedded, not just on call

Part of your team and aligned with your goals. Not just there when something goes wrong, but positioned to see around corners before issues arrive.

Right-sized for your stage

Whether you are pre-IND or preparing for launch, the level of support adjusts to where you are and what you need.

Experience

Career Highlights

2024 – Present

Law Offices of Sulin Shah

Chicago, IL

Founder & Legal Consultant / Fractional General Counsel

Serves as fractional General Counsel and compliance leader to multiple life sciences and healthcare clients. Guided a publicly traded rare disease company through headcount growth from 30 to 150+ employees, culminating in the successful launch of the first FDA-approved therapy for its target indication. Negotiated a $200M+ BARDA contract for a clinical-stage biotech developing government-funded medical countermeasures. Leads M&A execution and advises on corporate governance for a fast-growing veterinary care consolidator, including asset purchase agreements and acquisition integration.

2021 – 2023

PharmaEssentia USA

Chicago, IL / Burlington, MA

Vice President, U.S. General Counsel

Chief legal counsel for the U.S. subsidiary of a Taiwan-based rare oncology biopharma, with the U.S. operations representing approximately 85% of global revenues. Supported FDA approval and successful commercial launch of a treatment for polycythemia vera. Advised on initiatives driving a 100% year-over-year revenue increase post-launch and a 450% increase in parent company market capitalization. Counseled on a $462M global depository receipt offering and led an exclusive licensing transaction with a Latin America partner.

2020 – 2021

Orphazyme

Chicago, IL

Vice President, U.S. General Counsel

Built the U.S. legal, compliance, and human resources functions for a Denmark-based rare disease pharmaceutical company, growing the U.S. team from 4 to 36 employees in 16 months. Led the company's U.S. Nasdaq dual listing and periodic securities filings. Established contracting frameworks, market access programs, and a U.S. compliance infrastructure. Led extensive pre-launch preparation ahead of anticipated FDA approval, including build-out of commercial, market access, and medical affairs infrastructure. Played a key leadership role guiding the company through an FDA complete response letter, including restructuring efforts and resubmission strategy.

2007 – 2020

Takeda · Shire · Baxalta · Baxter

Chicago, IL / Cambridge, MA

Lead Counsel, U.S. Hematology (Takeda/Shire) · Senior Counsel (Baxalta/Baxter)

Served as lead legal counsel for the U.S. Hematology franchise (>$1.8B annual revenue) through Baxalta's spin-off from Baxter, Shire's $32B acquisition of Baxalta, and Takeda's $62B acquisition of Shire, one of the largest pharma deals in history. Guided multiple product launches and held progressively senior roles across legal, compliance, and business development through three major corporate integrations. Recognized as a top performer throughout, earning Shire's highest performance rating for 2016, 2017, and 2018.

2004 – 2007

McDermott Will & Emery LLP

Chicago, IL

Associate, Health Law & M&A / Private Equity

Began career at one of the country's preeminent healthcare law firms, practicing in the Health Law and M&A/Private Equity groups. Represented private equity clients, large hospital systems, and publicly and privately held corporations on transactions, including acquisitions, divestitures, and joint ventures.

Contact

Get in Touch

Inquiries of all kinds are welcome. Whether you need ongoing counsel, help with a specific matter, or just want to explore whether there's a fit.

sulin@sulinshahlaw.com LinkedIn